Troubleshooting Guide Cobas H 232 V4.0

cobas h 232 POC System
Trouble Shooting Guide
FOR TELEPHONE SERVICE AND TECHNICAL SERVICE

Valid for cobas h 232 with HBM 4
Trouble Shooting Guide cobas h 232 / Version 4.0 – Dec 2018 / Page 1
Document History
Date Version Modification Page
21.11.2008 V 1.1 Text modification 4, 9, 10, 11, 12, 20-49, 51-59, 61-77, 79-98, 100-116, 118-127
24.07.2009 V 1.2 Text modification 3, 44, 45, 46, 47
05.12.2010 V 1.3 Text modification 13, 14, 16, 23, 25, 26, 28, 29, 30, 31, 32, 33, 37, 38, 39, 40,
41, 46, 49, 55, 78-92,152-174, 178, 179
07.12.2011 V 1.4 General revision, new software All
01.10.2014 V 1.5 General revision All
19.02.2015 V 1.6 General revision and All
modification
31.05.2016 V2.0 General revision and All
modification for HBM 4
22.11.2017 V3.0 Text modification, removing of All
typos, addition of new to failure
backgrounds and known
workarounds. Category codes
and cause codes added.
11.12.2018 V4.0 Removing of I-005 All
Addition of failure background 54
and known workaround for E-
201
Important
The target group for the trouble shooting guide (TSG) differs between the country organizations. Some
countries are working with field service engineers, others with call agents, some with first level
investigation units, while some other countries carry out trouble shooting and fault findings in a repair
shop before a case is escalated.
Therefore, the trouble shooting guide has to be seen as guideline for all such groups and country
organization are asked to adapt their own documentation based on the TSG, on their service concept
and dedicated requirements from their specific markets or customer groups.
Complaints that cannot be handled or solved locally should be sent via the complaint handling system to
the queue "eRPD-PoC-MA" for detailed investigation in the Quality Assurance of the BA.
Confidential Material
Printouts or copies of this documentation in any form, including electronic copies, have to be handled as
confidential and must not pass into the hands of unauthorized recipients.
Languages
The cobas h 232 can work in different languages.
Only the English notices and error messages are described in this manual. Since other displays are put
with clear numbers, they simply can be assigned.
Content:
1. General Information ........................................................................................................................................................... 12
1.1 Explanation of Symbols ............................................................................................................................................ 12
1.2 Limitation ................................................................................................................................................................ 12
1.3 Product Inquiries and Complaints ............................................................................................................................ 12
1.4 Contact person for issues regarding this Trouble Shooting Guide ........................................................................... 12
2. Documentation ................................................................................................................................................................... 13
2.1 Update Service for this Manual ............................................................................................................................ 13
2.2 Explanation of Version ID.................................................................................................................................. 13
2.3 Detection of theinstruments firmware version....................................................................................................... 13
2.4 Reset of the meter .............................................................................................................................................. 13
3. Service Concept .................................................................................................................................................................. 14
3.1 Service Level ........................................................................................................................................................ 14
3.2 Intra-Company Warranty Period for Instruments ................................................................................................. 14
3.3 Local Warranty Period ......................................................................................................................................... 14
3.4 Complaint Management...................................................................................................................................... 14
3.5 Access to instruments error log .................................................................................................................................. 16
3.5 User Error Codes ....................................................................................................................................................... 17
4. Technical Data .................................................................................................................................................................... 18
4.1 Meter Specifications ............................................................................................................................................... 18
5. Components ....................................................................................................................................................................... 19
5.1 Overview of the meter and its accessories ............................................................................................................... 19
6. Trouble Shooting ................................................................................................................................................................ 24
Quick Access (Description) ................................................................................................................................................. 24
Errors without specific failure number............................................................................................................................... 24
Quick Access by Error or Information Number .................................................................................................................. 25
6.1 Errors When Powering On ............................................................................................................................................. 26
6.1.1 Blank Display .......................................................................................................................................................... 26
6.2 Information Messages ................................................................................................................................................. 27
I-001 27
I-002 28
I-003 29
I-006 30
I-007 31
I-008 33
I-009 35
I-010 36
I-014 37
I-018 39
6.3 Error Messages - Category: ID Errors ............................................................................................................................. 40
E-101 40
E-102 42
E-103 43
E-104 45
E-105 46
E-106 47
E-107 48
E-108 49
E-109 50
E-110 52
E-111 53
6.4 Error Messages – Category: Handling Errors ................................................................................................................ 54
E-201 54
E-202 56
E-203 57
E-204 58
E-205 60
E-206 62
E-207 64
E-208 66
E-209 67
E-210 68
E-211 69
6.5 Error Messages – Category: Error with Conditions ...................................................................................................... 70
E-301 70
E-302 71
E-303 73
E-304 74
E-305 76
E-306 77
E-307 78
E-308 79
E-309 81
E-310 83
E-311 84
6.6 Error Messages – Category: Measurement Errors ....................................................................................................... 85
E-401 85
E-402 87
E-403 89
E-404 93
E-405 95
6.7 Error Messages – Category: Self-Check Errors ........................................................................................................... 101
E-501 101
E-502 102
E-503 104
E-504 105
6.8 Error Messages – Category: System Errors ................................................................................................................ 106
E-601 106
E-602 108
E-603 110
E-604 112
E-605 114
E-606 116
E-607 118
E-608 120
6.9 Error Messages – Category: Communication Errors .................................................................................................. 122
E-701 122
E-702 123
E-703 124
E-704 126
E-705 128
E-706 130
E-707 131
E-708 132
6.10 Error Messages – Category: Database Errors ........................................................................................................... 133
E-801 133
E-805 135
E-806 136
E-807 137
7. Errors without displayed Messages .................................................................................................................................. 139
7.1 Error in Documentation ............................................................................................................................................... 139
7.2 Partial defectiveor faulty Display ..................................................................................................................................... 140
7.3 Sound not working ....................................................................................................................................................... 141
7.3 Visible Meter Defects ................................................................................................................................................... 142
7.4 Missing or Faulty Part ................................................................................................................................................... 143
7.5 Meter freezing during connection to DMS ................................................................................................................. 144
8. Error with samples ............................................................................................................................................................ 145
8.1 Sample Collection Errors ............................................................................................................................................ 145
8.2 Measurement does not start ..................................................................................................................................... 147
8.3 Values are not reproducible ....................................................................................................................................... 148
8.4 Errors in Reconstituting Control Solution .................................................................................................................. 149
9. Questionable Results with Blood...................................................................................................................................... 151
9.1 CARDIAC T Quantitative ............................................................................................................................................... 152
9.1.1 Values too low compared to laboratory method .................................................................................................. 152
9.1.2 Values too high compared to laboratory method................................................................................................. 153
9.1.3 Compared to patient data (history/ diagnosis/ treatment) the values are too high ......................................... 155
9.1.4 Compared to patient data (history/ diagnosis/ treatment) the values are too low .......................................... 156
9.1.5 Liquid Quality Control Test outside the Control Range ...................................................................................... 157
9.1.6 Difficulties to compare Troponin T values with Troponin I values ...................................................................... 159
9.2 CARDIAC Myoglobin .................................................................................................................................................... 162
9.3 CARDIAC D-Dimer ........................................................................................................................................................ 169
9.4 CARDIAC pro BNP......................................................................................................................................................... 177
9.5 CARDIAC CK-MB .......................................................................................................................................................... 184
9.6 Roche CARDIAC POC Troponin T ................................................................................................................................ 191
9.7 IQC .............................................................................................................................................................................. 198
9.7.1 Value outside of the confident interval ................................................................................................................ 198
9.7.2 IQC level II fails......................................................................................................................................................... 199
10. Wireless LAN ................................................................................................................................................................... 200
10.1 Wireless LAN ......................................................................................................................................................... 200
10.2 Trouble shooting WLAN............................................................................................................................................ 202
10.2.1 Updated instructions to install a new RF card................................................................................................... 202
10.2.2 Wireless communication not established ......................................................................................................... 202
10.2.3 Results not transmitted via WLAN .................................................................................................................... 203
11. Appendix ......................................................................................................................................................................... 204
11.1 Package inserts Roche CARDIAC strips.......................................................................................................................... 204
11.2 Lot Specific Values .................................................................................................................................................... 204
11.3 General Question for pre-analytics and sample preparation ...................................................................................... 204
11.4 General Remarks Sample Preparations: ................................................................................................................... 206
11.5 Cleaning of the Instrument.................................................................................................................................... 207
11.5.1 Cleaning of the instrument ONLY according to Operator manual. ................................................................... 207
11.5.2 Recommended cleaning/disinfecting solutions ................................................................................................ 207
11.5.3 Cleaning/disinfecting the exterior (meter housing) .......................................................................................... 207
11.5.4 Cleaning after contamination due to mispipetting ........................................................................................... 208
11.5.5 Cleaning the test strip guide cover....................................................................................................................... 208
11.5.6 Cleaning the visible area of the test strip guide .................................................................................................... 209
11.6 QC Recommendation................................................................................................................................................ 210
11.7 Picture Gallery .......................................................................................................................................................... 211
11.8 Ordering Information ............................................................................................................................................ 217
11.9 Category and Cause Codes ....................................................................................................................................... 220
11.10 Symbols and signs .............................................................................................................................................. 224
1. General Information
1.1 Explanation of Symbols
Please read carefully all text proceeded by the following symbols:
Warning!
This symbol warns of a situation that may pose a risk to your health (e.g. as a result of you
making wrong calculations).
Caution
This symbol indicates that your monitor is at risk of being damaged.
Important!
This symbol highlights important information that will help you get the most out of your system
1.2 Limitation
This Service and Trouble Shooting Guide reflect the knowledge about product and application at the time of preparation.
Any important changes will be incorporated into a subsequent edition of this manual.
In any case where information given appears to be contradictory, the package insert shall invariably take precedence.
This Trouble Shooting Guide was compiled by using Microsoft Word; all pictures are filed in TIFF or JPG format. The trouble
shooting guide must only be distributed in pdf format.
1.3 Product Inquiries and Complaints
Please send inquiries and product complaints only via the complaint handling system.
Complaints that cannot be handled or solved locally should be sent via the complaint handling system for detailed
investigation in the Quality Assurance of the BA.
1.4 Contact person for issues regarding this Trouble Shooting Guide
Dr. Antonia Pop-Karadavut
Telephone: +49 621 759 5429

Fax: +49 621 759 78 25429
E-Mail address: antonia.pop@roche.com
2. Documentation
2.1 Update Service for this Manual
This document has been screen-optimized. Find the latest version of this document in GRIPS
The Version ID for this trouble shooting manual is printed at the bottom of each page.
2.2 Explanation of Version ID
cobas h 232 / Version 4.0 / Dec 2018 / Page x

Monitor: cobas h 232
Version: 4.0
Date of edition: Dec 2018
Page: x
The system code for cobas h 232 is: KQ

Serial number start with: 03xxxxx
The system code for cobas h 232 with scanner is: KS

Serial number start with: 04xxxxx
2.3 Detection of theinstruments firmware version
Switch the instrument on. An additional screen displays the hardware and firmware versions installed before the instruments
main screen appears.
2.4 Reset of the meter
Switch the instrument on and keep the on/off button pressed for at least 12 seconds in order to reset the meter.
The meter will keep its current configuration; date and time have to be set.
3. Service Concept
3.1 Service Level
The cobas h 232 is not reparable in the field
Please forward defect systems to Roche Diagnostics GmbH, Mannheim only when advised from CIR (Complaint Investigation
and Resolution)
Please note the restrictions on shipment of battery packs
3.2 Intra-Company Warranty Period for Instruments
Since the year 2003 intra-company warranty is terminated.
Find up-to-date information in the ROCHE Intranet
3.3 Local Warranty Period
Local warranty is defined by the local sales organization.
3.4 Complaint Management
The complaint management is described on a divisional level (please refer to the divisional QM homepage).
3.4.1 LocalAssessment of Customer Complaints
Key elements for local assessment of customer complaints are:
A. Customer on the Phone:

- Roche Diagnostics person with acceptable knowledge of the complaint product
- Troubleshooting Guide at hand to be guided to the most efficient solution path
- PRI/PSI Decision Criteria and Screening Criteria as check list to identify potentially reportable complaints or potential
safety issues
- Appropriate call logging software with standardized failure descriptions
- Ask your customer to return the complaint product for further inspection and investigation only if the issue cannot be
solved on the phone or if you identify a PRI/PSI.
- Clearly identify which part of the product / system could be defective.
Example:
If the customer is reporting an error code on the meter display, the reason may be not only a defective meter, but also a
problem with strips/reagent or handling.
If you ask just for the meter, a potentially non-defective meter is replaced without need, but costs for CPS.
If you ask just for the strips, a potentially defective meter is still with the customer and you replaced strips without need, but
costs for CPS. In both cases the real customer problem may remain unsolved, potentially causing further complaints or
dissatisfaction.
B. Complaint product returned from customer to CPS:

Following the Troubleshooting Guide, Service Manual, User’s Manual or other supportive material, the cause of the complaint
should be understood.
B1. Strips are returned for inspection:

- Visual check of the material: crosscheck material / lot number and expiry date, defective parts, vial, unacceptable material
in the vial, signs for misuse or mishandling
- Check a strip/reagent with a well-performing instrument (as reference), if the complaint instrument is also available, check
too.
- If complaint strip/reagent and the instrument are performing well individually, but not running together, consider a system
issue, which most likely can be evaluated in the BA only.
B2. An instrument is returned for inspection:
- Visual check of the instrument for completeness, defects, broken parts, misuse, discharged batteries
- Switch on, check display test, standard functions, log file reading
- If both complaint strip/reagent and the instrument are performing well individually, but not running together, consider a
system issue.
All locally solved complaints have to be documented in your database using BA Standards.
C. Customer complaint cannot be handled or solved locally:
Complaints that cannot be handled or solved locally should be sent via the complaint handling system to the queue "eRPD-
PoC-MA " for detailed investigation in the Quality Assurance of the BA.
3.4.2 Reporting of Quality Issues "Locally Solved" in the Country organization
Data of "locally solved" quality issues should be entered onto the local complaint handling system electronically and must
contain information such as:
o Date of incident
o System involved (System Code)
o Product name(s)
o Global material number(s)
o Lot and/or serial number(s)
o Expiration date(s)
o Standardized failure (Error Code)
o Display message (Display Code)
o Detailed problem description (free text)
Attachments:
o Meters error log must be read out in DOC or PDF file format and must show clearly the different software and
hardware versions. The error log must be attached to the case
o For strip failure: Please get a digital picture showing the erroneous strip, best the sample application and the test
area. If possible, the picture should be taken shortly after the measurement failed.
3.5 Access to instruments error log
A feature in the instruments firmware allows access to the error log stored in the instrument.
Requirements:
- Cobas h 232 instrument (≥ version 03.00.00)
- Error Code Collection ≥ Version 7.2 (ECC Tool)
The ECC Tool has to be used to generate the “Password”. Use the tab “Extras” from the ECC Tool main screen to access the
Password Calculation (see picture below).
For more details refer to the HELP function build in to the ECC Tool software. Also, the relevant product or service bulletins can
provide further information on this subject.
The password must be generated depending of the instruments current system date (see picture below).
Continued on next page
The password than must be used on the cobas h 232 system, entered for the Administrator ID and a user can access the
error history and scroll through the error codes (see picture below).
An analysis of the error codes stored in the instrument can help to determine quickly, if
• an instrument must be requested for inspection,
• the instrument must be exchanged
• a work-around for a certain problem can be provided, or
• frequently user errors did appear.
3.5 User Error Codes

A list of User Error Codes can be found in the ECC Tool from on version 7.1
The list will be displayed as a PDF-file; it can be stored locally or printed if needed.
Back
4. Technical Data
4.1 Meter Specifications
Operating conditions and technical data

Temperature range 18-32 °C
Relative humidity 10-85% (no condensation)
Maximum altitude 4300 m
Position Always place the meter on a level, vibration-free surface when applying the
sample to the sample application area of the test strip. Once the sample has
been completely absorbed by the test strip, you can move the meter.
Measuring range Depends on test parameters

Memory 2000 Patient Test Results
500 QC Test Results
200 IQC Test Results
100 Strip Code Chips
100 QC Code Chips
4000 Patient List entries
5000 Operator List entries
Interface Infrared interface, LED/IRED Class 1

Supported barcodes Code 128, Code 39, Code 93, EAN 13, Interleaved 2/5, Codabar, GS1
DataBar Limited, QR Code, DataMatrix, PDF417, Aztec
Battery operation Universal battery pack (HBM4.x)

Mains connection Power adapter:
Input: 100-240 V AC (± 10%) / 50-60Hz / 350-150 mA
Output: 12 V DC / 1.25A
Number of tests with fully approx. 10 tests

charged battery
Safety class III
Automatic power-off Programmable 1 … 60 minutes
Dimensions 244 x 105 x 51 mm
Weight approx. 526g incl. handheld battery pack and scanner
Sample material
Sample type Heparinized venous whole blood
Sample size 150 µL
Interactions Refer to test strip package insert
Storage and transport conditions

Temperature range –25 °C to +70 °C
Relative humidity 10 to 85% (no condensation)
5. Components
5.1 Overview of the meter and its accessories
A Touchscreen
Shows results, information, icons and results saved in the memory. To select an option, simply touch the button
lightly.
C
B On/Off button
Press this button to power the meter on or off.
C Opening for sample application

Opening in the test strip guide cover that enables you to apply blood once the test strip is inserted.
D Test strip guide cover

Remove this cover to clean the area underneath (if it has become soiled, e.g., with blood).
E Barcode scanner G
Operator and patient IDs can be read using the integrated barcode scanner (serial number >KS02xxxxx). To
determine if your meter has this function compare the REF number on the meter identification plate to the
corresponding ordering information (list of REF numbers)
F
H
G Meter Identification Plate
H Wireless LAN Label

If the meter supports wireless connectivity: This label displays registration numbers that are specific to the meter
RF hardware.
I Test strip guide
Insert the test strip here.
J Infrared (IR) window

Supports data communication with the (optional) Handheld Base Unit. Covered by the semi-transparent rear panel.
K Connection socket for power adapter

Plug in the power adapter here.
L Code chip slot

Insert the code chip here.
M Charging terminals
Used for power supply and/or charging the battery pack when the meter is docked in the (optional) Handheld Base
Unit.
I
J
KLM
N Universal Battery Pack O Power adapter

Powers the device. Powers the device and charges the battery pack.
The meter can be operated with the rechargeable battery pack only or together with the power adapter or the
(optional) Handheld Base Unit, which both charges the battery pack when inserted.
Insert the battery pack even when always using the power adapter or the Handheld Base Unit.
This ensures that you will not lose the date and time settings if the power goes out. Results are retained in
the memory together with the corresponding date and time, as well as all other settings, even when no
battery pack is inserted.
To save power, the meter can automatically power itself off or go into standby mode, if no buttons are
pressed or new test strips are inserted. When the meter powers itself off, all test results obtained up to that
point remain in memory and the settings are retained (see “Auto off” in the chapter entitled “Data Handling
setup” in the Operator Manual).
Test strip
P
Q
P Test area R Barcode

This area is evaluated by the meter via the camera. Assigns the strip to the corresponding code chip. The
barcode is automatically read by the meter when the
Q Sample application area strip is inserted into the test strip guide.
The sample is applied to this area after inserting the
test strip in the meter. S Code chip
Contains strip lot specific data.
Continued on next page
Handheld Base Unit
T
V
Y
X
W
Z
T Charging contacts X Data ports (Ethernet/RJ45 and USB)

Used for charging of the handheld battery pack. For connecting the device to a Data Management
System (DMS).
U Status indicator
Lights up when power is connected, charge indicator. Y Connection socket for the handheld power supply
unit. Here you can plug in the power supply unit
V Infrared (IR) window provided.
For communication with the meter.
Z Removable cover for configuration switch
W Extension piece The switch sets the mode of operation for the hand-
For cobas h 232 meter. held Base Unit.
The Handheld Base Unit can be ordered separately. For detailed information on usage and
configuration please consult the operator’s manual of the Handheld Base Unit.
6. Trouble Shooting
The access to the failure codes and possible solution is provided via quick links in the document.
Quick Access (Description)

Press “STRG + left mouse” to open the link.
Press “STRG + left mouse” on the link labeled with “Back” to return to the page with the error overview
Work down the steps defined in the section “Procedure / Steps for trouble shooting” of each failure
description to come to a solution for the reported failure
Errors without specific failure number
Error when powering on
Sound not working
Display failures
Errors in Documentation / Labelling failure
Visible Meter Defects
Access to Instruments Error log / Password of the day
Quick Access by Error or Information Number
E 101 E 201 E 301 E 401 E 501 E 601 E 701 E 801 I 001
E 102 E 202 E 302 E 402 E 502 E 602 E 702 I 002
E 103 E 203 E 303 E 403 E 503 E 603 E 703 I 003
E 104 E 204 E 304 E 404 E 504 E 604 E 704
E 105 E 205 E 305 E 405 E 605 E 705 E 805
E 106 E 206 E 306 E 606 E 706 E 806 I 006
E 107 E 207 E 307 E 607 E 707 E 807 I 007
E 108 E 208 E 308 E 608 E 708 I 008
E 109 E 209 E 309 I 009
E 110 E 210 E 310 I 010
E 111 E 211 E 311
I 014
I 018
Press Back to get on this page
6.1 Errors When Powering On
6.1.1 Blank Display
Instrument cannot be powered on.
Possible cause: Voltage low, handheld battery pack not charged, power management failure, on/off button, mechanics
Background: In some cases it was observed that the memory of the instrument was corrupted, the software could not be
loaded upon start-up. In such cases, the screen appears dark or only the Roche logo is displayed and remains on screen.
The instrument needs to be requested for inspections.
Other failure sources: Refer also to Quality Notification QN-CPS-2017-055

• Check if the latest Software is installed in order to avoid a failure in the meter’s the power management.
• On/Off button damaged
• Housing or mechanical failure
Procedure / Steps for trouble shooting
Step Action
1 Check the electrical voltage of the power outlet for the connection of the handheld cobas h 232.
2 Connect the handheld power supply unit of the cobas h 232 to the mains. Does the LED light up?
If not, exchange the handheld power supply
3 Keep the On/Off button pressed for a few seconds until a screen display appears or you hear a beep.
If the complaint persists and the meter is equipped with the latest SW version request the cobas h 232 and
handheld power supply for inspection
Category Code Cause Code FLIU Code Error

Number
User Interface (Display / Electronic Failure
Touch)
Back
6.2 Information Messages
I-001
The battery is getting low.

Attach external power supply or return the meter to the
docking station.
Possible cause: Handheld Battery Pack is empty
Background: Voltage of handheld battery pack is getting low
Step Action
1 Insert a fully loaded handheld battery pack (see description in Operator’s Manual) or use a handheld power supply.
2 Request the cobas h 232 and handheld battery pack for inspection

Number
Information / Customer Operator Error /
Request Technique / Handling
Back
I-002
The patient ID you entered is not on the list
Possible cause: The patient ID you entered is not on the list
Background: Patient ID entered was not uploaded to the meter and does therefore not exist on the meter’s patient list
Step Action
1 Enter a correct patient ID from the patient list on the meter
2 Upload a correct list to the meter and choose a valid patient ID
If the complaint persist request the cobas h 232 for inspection

Number
Use / User Error Operator Error /
Technique / Handling
Back
I-003
„Text can be customized“
Elimination of Problem
Possible cause: This is the log-in message
Background:
-n/a -

Number
Back
I-006
Only a few tests left until the maximum number of tests are
reached. Contact your Roche representative.
Elimination of Problem
Possible cause:
Only a few tests left until the maximum number of tests are reached.
Remarks:
Amount of remaining tests is displayed in the message.
The instrument software alerts if ten (10) measurements are left before the maximum numbers of measurements is
reached.
Background:
After reaching the maximum amount of 5500 measurements the instrument will be disabled for further measurement and
needs to be exchanged
Step Action
1 After reaching the maximum amount of measurements the instrument needs to be exchanged.
Inspection or further investigation of the instrument is not needed.

Number
Back
I-007
The wrong code chip is in the meter.

Please remove the code chip and insert the right one.
Possible cause:
• The correct code chip for the used lot is missing or cannot be read.
• Meters date and time is not set to the current date and time or is pointing to a future date and time.
Background:
The code chip is missing or cannot be read.
Note: when using a new strip lot AND a new Quality Control (QC) lot at the very same time.
Both code chips have to be inserted after each other or the error message persists in all cases
Step Action
1 Ensure that the meters date and time is set to the current date and time.
Insert the missing code chip corresponding to the test strip into the meter.
Note: When inserting the code chip, make sure that the labeling faces upwards. Ensure that test strip and
code chip have the same lot number.
2 Insert and remove the code chip a few times
3 Clean the contacts on the reverse side of the code chip
4 Send the customer a new code chip of the same strip lot, or exchange the test strip package if necessary.
If the complaint persist request the cobas h 232 and code chip for inspection
Back

Number
I-008
Operator %s, please login. Otherwise the measurement

will be aborted and the result will not be stored.
Remark: %s is the name of the current operator.
Possible cause: wrong operator is logged in
Background:
- The scanned operator ID is not in the operator ID list.
- The manually entered operator ID is not in the operator ID list
Operator ID
For further information see description in Operator’s Manual.
Step Action
1 Check the operator ID. Enter the correct operator ID
If the complaint persist continue with step 2
2 Check whether another Operator ID can be scanned?

3 Check whether the host communication is activated?

If the complaint persist request the cobas h 232 for inspection if the handheld base unit can be clearly excluded
as a source for the reported failure
Number
Back
I-009
A comment is required if you reject a result. Please enter

a comment.
Possible cause: Result was rejected but no comment was entered
Background:
- If a result is rejected a comment must be provided.
Operator ID
Step Action
1 Fill in a comment as requested

Number
Back
I-010
Observer “Alan Smithee” (example name), please log in

to proceed. Otherwise the OTS test will not be complete.
Possible cause:
Background:
-
Operator Log in from Observer is missing

Step Action
1 Observer has to log in in order to continue and to complete with the OTS test

Number
Back
I-014
Enter a secure URL to this feature
Possible cause:
Background: No or a wrong URL configuration for the transmission is on the meter

-
URL is missing. Results cannot be uploaded to the web

based service.
Step Action
1 Fill in the secure URL and ensure that the required parameter are correctly configured
If the error persists after it was verified that the secure URL and the required parameter are configured correctly
the meter should be rebooted
2 If than the failure persist, the meter should be requested for inspection
Number
Back
I-018
Battery low.
Measurement can only be performed with external power
supply remaining attached.
Possible cause: Battery is low.
Background:
- Battery is low, external power supply must be attached in order to carry out the measurement and to change the
battery pack
Operator ID
Step Action
1 Attach the external power supply in order to charge the battery pack
2 Repeat the measurement after the battery pack was fully loaded

Number
Back
6.3 Error Messages - Category: ID Errors
E-101
A patient ID is required.
Please enter a valid patient ID.
Possible cause:
The scanned patient ID is not in the patient ID list.
Other reasons for this failure:

• Barcode label damaged
• Barcode type not supported.
Background: Refer also to the list of supported barcode types in the operator manual
Patient ID: Further information can be found in the description in the operator’s manual.
Step Action
1 Enter a valid Patient ID.
2 Check the patient ID. Enter the correct patient ID manually.
3 Check whether the host communication is activated
If yes, contact the system administrator / POC Coordinator.
Number
Back
E-102
Patient ID was not found on the list of valid patient IDs.

Enter a valid patient ID.
Possible cause: Invalid patient ID
Background:
Patient ID: Further information can also be found in the description in the operator’s manual.
Step Action
1 Check the patient ID. Enter the correct patient ID manually.
2 Check whether the host communication is activated.
3 If required, create a new patient and upload the correct patient list to the instrument
If the complaint persists contact the system administrator / POC Coordinator

Number
Back
E-103
An operator ID is required.
Enter a valid operator ID.
Possible cause:
• The scanned operator ID is not in the operator ID list.
• The manually entered operator ID is not in the operator ID list

Background:
Refer also to the list of supported barcode types listed in the operator manual.
Operator ID
Further information see description in Operator’s Manual.
Step Action
1 Check the operator ID. Enter the correct operator ID
2 Check whether another Operator ID can be scanned
3 Check whether the host communication is activated
If the complaint persist contact the system administrator / POC Coordinator
Number
Back
E-104
The ID was not found on the list of valid operator IDs.

Enter a valid operator ID or see your System Administrator.
Possible cause: Invalid operator ID
Background:
Step Action
1 Check the operator ID. Enter the correct operator ID manually.
2 Check whether the host communication is activated.
3 If required, upload the correct operator list to the instrument

If the complaint persists contact the system administrator / POC Coordinator

Number
Back
E-105
Invalid operator password. Please enter your password

again or see your System Administrator / POC Coordinator.
Possible cause: invalid operator password was entered
Background:
Step Action
1 Please enter your correct password
If the complaint persists please contact your System Administrator / POC Coordinator.

Number
Back
E-106
A comment is required for this result
Possible cause: The result was rejected and a comment was not provided
Background:
Step Action
1 Add at least one comment to result.
A more detailed description of this feature can be found in the cobas h232 operator’s manual

Number
Back
E-107
There are no operators loaded in this meter. In order to

continue, operators must be downloaded.
Please see your System Administrator / POC Coordinator
Possible cause: No operator loaded
Background:
Step Action
1 Dock the instrument and download the operator list.
If the problem persists, please contact your System Administrator / POC Coordinator.

Number
Back
E-108
The passwords you entered do not match. Please enter

password again.
Possible cause: Password mismatch
Background:
Note: Only the Supervisor password can be reset on the instrument by use the “Password of the Day”
Operator passwords must be reset or changed by use of the DMS
Step Action
1 Fill in the correct password.
If the problem persists, please contact your System Administrator / POC Coordinator

Number
Back
E-109
The scanned barcode is invalid. Scan a valid barcode or

see your System Administrator / POC Coordinator.
Possible cause:
The barcode with the operator ID/patient ID cannot be read.

Background: The barcode cannot be read.
Refer also to the list of supported barcode types listed in the operator manual.
Step Action
1 Scan the correct barcode
2 Ensure that the correct barcode type is configured for the meter and upload the configuration file if needed.
3 If the red light from the barcode scanner is visible, see your System Administrator / POC Coordinator.
If the red light from the barcode scanner is NOT visible, request the cobas h 232 for inspection
Number
Back
E-110
The operator ID is invalid. The operator who started the

test must log in again.
Possible cause: Wrong operator did log in
Background: Another operator did start the test
Step Action
1 Operator who started the test must log in again

Number
Back
E-111
The observer ID is invalid. The observer supervising the

current OTS test must log in again.
Possible cause: A wrong observer tried to log in
Background: OTS Test is carried out and the observer needs to log in again.
Step Action
1 The observer supervising the current OTS test must log in again.
Otherwise the OTS cannot be finished and must be repeated again.

Number
Back
6.4 Error Messages – Category: Handling Errors
E-201
The strip lot with the code “74646” has expired. Please
check the meter's date setting and use a non-expired strip
lot.
Remark: “74646” is a placeholder for the used code

number.
Possible cause: Strip Lot Expired
Background:
Other reason for this failure:
The code chip number clearly identifies the used test strip lot and the corresponding code chip. The process of creating the
code chip number does not prevent the repeating of the number. This leads to the situation that a meter has already stored
the code chip data of an old test strip lot. In this case, when inserting a new test strip lot containing the same code chip
number, the meter doesn’t request the operator to plug in a new code chip. Since the meter has already stored the old
code chip data with a repeated number the new test strip is detected as expired and triggers the Error 201.
Workaround for this issue:
• The customer needs to check first in case of Error 201 if the strip lot is expired or if the date on the meter
needs to be corrected. In case the strips are expired, a new unexpired lot has to be used.
• If strips are not expired and date on the instrument is correct, there is a workaround for the customers to delete
the code chip data manually by performing a reset of the test parameters as described in the Operator’s
Manual of the instrument (cobas h 232 HBM 4.xx OM V6 page 108, cobas h 232 HBM 3.xx OM V4 page 84).
Step Action
1 Check and, if required, correct the meters date setting.
2 Use a test strip and code chip from a different and not expired strip lot.
3 Clean the contacts on the reverse side of the code chip.
Re-insert the code chip.
If the complaint persist request the cobas h 232, strips and code chip for inspection

Number
Back
E-202
The control lot has expired. Please check the meters date
setting and use a non-expired control lot.
Possible cause: Control Lot Expired
Background:
Step Action
1 Check and, if required, correct the meter’s date setting.
2 Use a control lot and code chip from a different and not expired control lot which can be used with the current strip
lot
If the complaint persist request the cobas h 232, control solution and control code chip for inspection

Number
Back
E-203
The lot with the code 1234 is not allowed on this meter.
Please see your System Administrator / POC
Coordinator.
Remark:
1234 is a placeholder for the the used code number.
Possible cause:
• Lot not allowed, configuration of the system via DMS disallows the lot for the specific meter
• If such a failure appears ensure that that the function "code-key upload only with POCT 1-A" is NOT activated on
the meter, otherwise no code key information can be stored in the meter so far as an upload of such data is
expected. After deactivation of this function, the code-key will be read from the device as required.
Background:
Step Action
1 Use another allowed strip lot on this meter.
Ensure correct configuration of the meter.
2 Please see your System Administrator / POC Coordinator.

Number
Back
E-204
The barcode on the test strip cannot be read. Please check

the barcode on the test strip and restart the test.
Possible cause: The barcode on the test strip cannot be read.
Make sure that no bright light or direct sunlight enters the strip guide.
Ensure that the instrument is on a flat vibration free surface.
Background: The error can be cause by
Jammed flap in front of the strip insert. Flap of the strip insert is squeezed and remains in up position. This
simulated an inserted strip; BCR is not activated upon insertion of a new strip. Thus, a new strip will not be
detected; a new measurement cannot be started. More details can be found also in the Quality Notification
QN-RPD 2015-020.
The flap was jammed or damaged by wrong, mostly tilted strip insertion. More details can be found also in
the Quality Notification QN-RPD 2015-020
Defective electronics of the BCR
A visual inspection of the strips backside, the used strip or a digital picture of the strip might also be of a help for a detailed
root cause analysis of the failure.
The abovementioned failure can also point towards a contaminated optical system of the barcode reader, a contaminated
strip insert or strip guide.
Possibly the instruments error code can provide more information
Step Action
1 Check for the barcode label on the reverse side of the test strip and if needed clean the barcode sticker.
2 Make sure that test strip is properly inserted in the test strip guide.
3 Clean the instrument according to the description in the Operator’s manual.
4 Repeat the test with a new test strip
5 Reduce ambient light and restart the test.

If the complaint persist request the cobas h 232 and the used strips for inspection

Number
Electronic systems Electronic Failure
(instrument)
Back
E-205
Strip removed during test.

Repeat the test and use a new test strip if necessary.
Possible cause: A test strip was removed by the operator during testing
Background: Another reason for this error code can be contamination of the test strip insert or test strip port.
- Strip does not remain in correct end position during the test,
- Micro switch for strip detection is blocked or defective.
Instrument and test strip guide must be cleaned according to the guidelines from the operator manual.
Step Action
1 Remove the strip and boot the instrument.
Ensure that a failure free boot sequence was carried out before new measurement is started.
2 Switch the cobas h 232 off.

Unplug the handheld power supply.
Remove the handheld battery pack from the cobas h 232.
Wait 5 till 10 seconds
Fit a fully loaded handheld battery pack back into the cobas h 232.
Reconnect the handheld power supply.
Switch the cobas h 232 on again.
3 Repeat the test with a new test strip.
Number
Back
E-206
Strip cannot be recognized correctly.

Please check the test strip and restart the test.
Possible cause: Strip Error
Background: Another reasons for this error code is contamination of the test strip insert.
- Strip cannot be inserted completely
- Micro switch for strip detection is blocked or defective.
Instrument and test strip guide must be cleaned according to the guidelines from the operator manual.
Step Action
1 Please check the test strip and restart the test.
2 Use another strip of the same lot and restart the test.
3 Use a strip from another valid lot and restart the test.
Number
(instrument)
Back
E-207
The code chip is invalid.

Remove the code chip and restart the test
Possible cause: Code Chip Error, the code chip is missing or cannot be read.
Background: If the code chip slot is damaged it is possible that the code chip cannot be inserted or will not be recognized
Note: When using a new strip lot AND a new quality control lot (QC) at the very same time both code chips have to be
inserted after each other or the error message persists.
When inserting the code chip, make sure that the labelling faces upwards. Test strip and code chip must
have the same lot number.
Step Action
1 Insert the missing code chip corresponding to the test strip lot into the meter.
2 Insert and remove the code chip several times.
3 Clean the contacts on the reverse side of the code chip. Re-insert the code chip.
4 If necessary exchange the test strip package in order to use a new code chip.
If the complaint persist request the cobas h 232 and code chip for inspection
Number
Back
E-208
The test strip was inserted too quickly. Please restart the
test.
Possible cause: The barcode on the test strip cannot be read. The test strip was inserted too quickly
Background:
Step Action
1 Please restart the test. Be sure not to insert the test strip too quickly into the test strip guide

Number
Back
E-209
The test strip was inserted too slowly. Please restart the
test.
Possible cause: The barcode on the test strip cannot be read. The test strip was inserted too quickly
Background:
Step Action
1 Please restart the test. Be sure not to insert the test strip too slowly into the test strip guide

Number
Back
E-210
A quality control test must be performed. Continue with

performing a quality control test
Background: Most likely the instrument is in QC logout. A quality control test must be performed in order to release the
instrument from this status.
Step Action
1 Continue with performing a quality control test.
Refer to the Operator Manual and perform a quality control test.

Number
Preanalytics / Sample Operator Error /
Handling Technique / Handling
Back
E-211
The sample application cover was removed during a

test.
Please repeat test.
Possible cause: Sample application cover is open or not in position
The sample application cover is a spare part and can be ordered separately if damaged or lost
Background:
Step Action
1 Close the sample application cover and repeat the test.
If the cover is closed correctly and the problem persists, request the cobas h 232 for inspection

Number
Back
6.5 Error Messages – Category: Error with Conditions
E-301
The date is invalid. Please enter the correct current date

and time
Possible cause: Invalid date
Background: The date set on the instrument is invalid.
Step Action
1 Set the correct date and time in the "Setup" menu.

Number
Back
E-302
The battery is too low. No more tests can be performed.

Please replace or charge the battery pack.
Possible cause: Voltage of handheld battery pack too low. No more tests can be performed.
Background: Voltage of handheld battery pack too low. If no counter-measurements are taken after the error message was
displayed, the instrument can later on release in example an error E-705 as the low voltage might lead to a loss of the
connection to the measurement module or other connected modules of the meter.
Appearances of other following failure have been observed, too, but are clearly related to the drop of the voltage due to the
low battery. Such failure can be: System Error (E-604 till E-608, E-705)
Refer also to the instruments error log
Step Action
1 Insert a fully loaded handheld battery pack (see description in Operator’s Manual).
2 Connect the meter to the handheld power supply unit to recharge the handheld battery pack.
3 Shines the LED on the handheld power supply?

If not, connect the handheld power supply to mains correctly
If yes, exchange the handheld power supply in order to charge the battery correctly
If the complaint persist request the cobas h 232, handheld power supply and the used battery pack for inspection
Number
Power Supply / Battery Operator Error /
Back
E-303
The maximum number of tests has been reached.

Contact your Roche representative.
Possible cause: The maximum number of tests has been reached
Background: When this error is displayed, a maximum amount of measurements has been reached.
The instrument software alerts if ten (10) measurements are left before the maximum amount of measurements is reached.
If the maximum amount of measurements is reached the instrument will be disabled for further measurements.
The amount of measurements is also displayed in the instruments error log
Step Action
1 After reaching the maximum amount of 5500 measurements the instrument will be locked and need to be
exchanged.

Number
Back
E-304
The meter is too cold or too warm to measure correctly.

Turn the meter off and repeat after 30 minutes at room
temperature.
Possible cause: Ambient Temperature
The temperature specifications for testing are: 18 °C - 35 °C (64 °F - 95 °F)
Do not accelerate the heating or cooling process of the cobas h 232 or the test strips by using heaters, cold
storage rooms, microwaves or any other devices. Sunlight shining directly on the instrument may produce
high temperatures.
Background: The temperature of the meter is too warm or too cold
This failure can also appear if the instruments temperature sensor is damaged or torn off, in example due to a fall or drop the
instrument.
Step Action
1 Check the room temperature and observe the temperature specifications. If necessary, go to a room that meets the
temperature specifications.
Restart the test after 15 minutes.
Number
Back
E-305
The meter memory is full.

Please dock your meter or disable this setting.
Possible cause: Memory Full
Background:
If you are not using a computer/host system, disable this setting. Then, with each new test performed, the
oldest data will be overwritten
Note: It is assumed here that the handheld base unit is working without failure and is configured accordingly.
Step Action
1 Please dock your meter to transfer the results to the DMS.
2 Check the meter settings for data handling (see description in Operator’s Manual). Enabled usage of a computer to
transfer data to the specified host after docking of the instrument.

Number
Use / User Error Operator Error / Technique
/ Handling
Back
E-306
Ambient light is too bright.

Remove meter from direct light and repeat test
Possible cause: Ambient light is too bright
Background: It might be an indication for a Purple Plaque failure if this failure appears on instruments with serial numbers
below:
- KQ0120000
- KS0210000
Refer also to the instruments error log and to the Product Bulletins on this subject.
Step Action
1 Remove meter from direct light and repeat the test.
2 Reboot the instrument.
If the complaint persist after the reboot request the cobas h 232 for inspection

Number
/ Handling
Back
E-307
No battery pack has been detected. Please ensure that

the battery pack has been correctly connected.
Possible cause: Batteries in Meter
Background: The meter may only be operated with the hand-held battery pack inserted.
This failure was also observed under circumstance where the main power suddenly drops or a voltage peak appears which
cannot be compensated from the handheld power supply anymore.
Step Action
1 Check whether battery pack is inserted and correctly connected?
Insert a fully charged handheld battery pack into the meter.
If the complaint persist request the cobas h 232 and the handheld battery pack for inspection

Number
Power Supply / Battery Operator Error / Technique
/ Handling
Back
E-308
Meter temperature is elevated. Functionality of the meter

is reduced.
Please switch off the meter to cool down for several
minutes.
Possible cause: Meter temperature is elevated.
Background: Meter was operated in a too hot environment
Step Action
1 Switch off the meter
2 Wait 20 minutes in order for the meter to cool down
3 Check the environmental temperature and verify that the meter can operate under the current conditions.
Note: Meter specification and temperature conditions can be found in chapter 4
4 After meter has been cool down, reboot the meter and operate it normally
5
If the problem cannot be solved after the meter was cooled down and the meter is not working correctly under
normal conditions, request the cobas h 232 for inspection
Number
Back
E-309
The meter is outside the operational temperature limits.

Meter will power off.
Restart the meter after several minutes
Possible cause: The meter is outside the operational temperature limits
Background:
Step Action
2 Bring meter to specified environmental temperature and verify that the meter can operate under the current
conditions.
Note: Meter specification and temperature conditions can be found in chapter 4
4 After meter has been reached the specified temperature, reboot the meter and operate it normally
5 If the problem cannot be solved after the meter was brought back to normal operating conditions request the
cobas h 232 for inspection
Number
Back
E-310
The battery is critically low.

Attach external power supply immediately. The meter will
be powered down.
Possible cause: The battery is critically low
Background: Battery is getting critically low as it was not charged over a longer time frame.
Step Action
1 Switch off the meter if not powered down already
2 Charge the battery pack as defined
3 If the error message occurs with a fully loaded battery pack again, the battery pack must be exchanged
4 If the error message persists after a fully loaded and retention new battery is used, the meter and the old battery
pack must be exchanged and requested for an inspection

Number
Power Supply / Battery Operator Error /
Back
E-311
Invalid battery pack. Please replace with valid battery

pack or contact Roche representative.
Possible cause: Invalid battery pack
Background: Invalid battery pack
Step Action
2 Insert a specified and loaded battery pack
3 If the error message persists after a fully loaded and a specified retention new battery is used, the meter and the
old battery pack must be exchanged and requested for an inspection

Number
Power Supply / Battery Component wrong /
damaged
Back
6.6 Error Messages – Category: Measurement Errors
E-401
Sample detection has failed. Remove the test strip and

repeat the test using a new test strip, if necessary.
Possible cause: the sample was not detected
This error may be caused by sample-specific flow characteristics. The sample flows too slowly on the
test strip.
Make sure that no bright light or direct sunlight enters the instrument near the test strip guide.
Background: Sample detection has failed.
No sample application was detected within the prescribed time.

Possible causes:
- Too little volume of the sample was applied
- The sample is e.g. very viscous and runs through the test strip fleece very slowly.
Refer also the “Picture Gallery”
Step Action
1 Remove the test strip and insert a new test strip. Repeat the
test.
2 Ensure that exactly 150 µL of sample is applied? Use the Roche Cardiac pipette.
3 Repeat the test with a new test strip and precisely 150 µL of sample.
4 Was the test strip completely soaked?
If not, repeat the test with a new test strip and precisely 150 µL of sample.
5 Is an inhomogeneous sample flow visible on the test pad of the strip?

Refer also to the “picture gallery” in this trouble shooting guide
If yes, check sample using a different analytical system. The sample cannot be used with the Roche Cardiac
strip
If an homogeneous sample flow is visible on the test pad of the strip, request the cobas h 232 and the strips for
inspection

Number
Test strip / disk defective (no Operator Error /
questionable results) Technique / Handling
Back
E-402
A test strip error was detected. Check your procedure and

repeat the test, using a new test strip and necessary.
Possible cause: Strip faulty / disturbed sample flow
Background: Other reasons for this failure:

The failure can be released if the instrument recognizes a not linear or disturbed sample flow on the strip.
Refer also to the “Picture gallery”.
• In most cases it was observed that residues from wrong or inadequate cleaning of the meter’s inside lead to this
failure. Also objects such as cotton fluffs or fibrous material remaining penetrated into the optical system will cause
this failure.
• In some rare case it was observed that contamination of the optical system in combination with a darker strip
background has released this error. In such a case, exchange of the current strip lot can solve the issue locally.
• In some rare case it was observed that contamination of the optical system caused by strip abrasion leads to an
abort of the measurement. The disturbance of the digital image by dust or particles is too high and cannot be
compensated anymore. The measurement will be aborted in such a case. Wrong or inadequate cleaning
contributes to the appearance of the failure.
• In some case it was observed that the flap at the strip insert was jammed and remains in upper position. (Refer
also to E-204). This will prevent the activation of the bar code reader upon strip insertion. As a consequence a strip
is not recognized. Failure is visible when inspecting the flap.
• In a rare case it was observed that a deviation of the control line position on the strip can be a root cause for the
released error. In such a case, a use of a new strip or the exchange of the current strip lot can solve the issue
locally.
Independent from the software version, the failure can also be related to Purple Plaque failure (instruments serial number
< KQ0120000 and < KS0210000)
Step Action
1 Remove the test strip and reboot the instrument.
- Switch the cobas h 232 off.
- Unplug the handheld power supply.
- Remove the handheld battery pack from the cobas h 232.
- Wait 5 till 10 seconds
- Fit a fully loaded handheld battery pack back into the cobas h 232.
- Reconnect the handheld power supply.
- Switch the cobas h 232 on again.
- Repeat the test.
Ensure that a failure free boot sequence was carried out before a measurement is started.
2 Remove the test strip, insert a new test strip and repeat the test.
3 Remove the test strip and repeat the test with a new test strip from another lot.

Number
Test strip / disk defective (no Damaged
questionable results)
In case of a faulty or squeezed flap at the strip insert:

Number
Chassis, Housing Mechanical Failure
Back
E-403
A dosing error was detected. Remove the test strip and

repeat the test using a new test strip, if necessary.
Note:
Upon appearance of this failure it is important to know when this failure did appear.
Knowledge about the correct time can deliver valuable information for the next steps.
A: Does the error appear, when the sample was applied and instrument is warming up?
B: Does the error appears, approximately 5 minutes or later after begin of the measurement?
Note that interferences of the sample can cause the line to disappear.
Preparation:
Heparinized venous whole blood is used as sample material. For each test with a cobas h 232 meter a quantity of exactly
150 µL is needed.
Tubes:
There are color codes for tubes but the color of the tube's plastic cap is not standardized across manufacturers. In all case
refer to the package inserts for the information regarding the usage of tubes. Only tubes listed there have been evaluated.
Note: Using the wrong tube will make the blood sample unusable.
Storage:
If the sample, for which reasons so ever cannot be used directly, it must be stored in a cool location, preferably in a
refrigerator or cool box. The optimal temperature for the storage of blood samples is 4° Celsius.
Variations in temperature should not exceed 2 - 8° Celsius.
Sample must not be centrifuged!
Sample Application:
Mechanical action pipettes require a relatively high level of care to ensure they are always functioning correctly. Corrosion
or leaking within the pipette can occur and these failures are not easily detectable by the user, so incorrect volumes can be
applied.
Use the Roche CARDIAC pipette to draw exactly 150 µL (to the blue mark on the pipette) heparinized blood from the blood
collection vial. Make sure the sample contains no air bubbles. Apply the entire sample to the application area of the test
strip.
Always place the meter on a level, vibration-free surface while applying the sample until the necessary sample has been
absorbed completely by the test strip.
The pipette should be held in a vertical position to avoid spilling of the blood sample. Also, do not touch the test strip with
the pipette and assure that the needle does not penetrate the strip.
A: In case that the error appears, approximately 5 minutes or later after begin of the measurement.
Background: The instrument warms up the strip and waits approximately 3 to 5 minutes to detect the sample flow. While
the sample is flowing along the strip, the background color of the test field will change and the control line is building up. If,
in example due to a pre-analytic failure, the sample will not flow or not flow correctly, the line cannot be detected from the
instrument and the measurement will be aborted with an error message.
Possible cause:
• Overdosing (see picture)
• Wrong heparinization of the sample,

• Wrong tubes (refer to package insert),
• Handling (preparation, pipetting, etc.)
• Interferences from drugs or rheumatic factors? In such a case the failure will appears always with the same patient
sample. Check medical history and drug list against information from the package inserts.
Step Action
1 Repeat the measurement with another strip from the same lot
2 Repeat the measurement with another strip from another lot
3 If the complaint persist request the cobas h 232, strips and code chip for inspection
Back
B: In case that the error appears when the sample was applied and instrument is warming up.
the sample is flowing along the strip, the background color of the test field will change and the control line is building up. If,
in example due to a pre-analytic failure, the sample will not flow or not flow correctly, the line cannot be detected from the
instrument and the measurement will be aborted with an error message.
Possible cause:
If the measurement is aborted at this time, there is a very high chance that interferences in the sample have caused the
control line to disappear
Protection against infection:

Observe always the general precautions and guidelines relating to blood sampling when collecting a
sample
A visual inspection of the strip can provide information, too. If possible, (or if needed) the strips cover can be opened to
investigate the strip visually for the following effects:
• Background of test field too reddish, line not visible anymore.
• Too much sample applied.
• Flow of the sample along the strip
• Damages of the strips material
Other possible causes:

High Dose Hook Effect (only on some assays)
The High Dose Hook Effect can appear as an artifact on some assays, which causes the reported quantity of the marker
to be falsely low when the quantity is high.
Reason for that is the disappearance of control line is a very high analyte concentration. Finally there are no free antibodies to
form the line or antibodies are "washed" out from the already formed line. The instruments camera notices the disappearance
of the former existing control line; the instrument aborts the measurement and releases an error instead.
Step Action
1 Check handling and pipetting (i.e. are Roche Cardiac Pipettes used?)
2 Check medical history and drug list, check against package insert and discuss it with the doctor to identify (or to
rule out) possible interferences
3 If the root cause cannot be identified, ask for a patient sample to be investigated in Mannheim.
Obtain further information and instructions prior to the shipment of the sample.
Number
Preanalytics / Sample Operator Error / Technique
Handling / Handling
Back
E-404
An error with the control line on the strip was detected.

Check your procedure and repeat test with a new strip.
Possible cause:
- Too little sample was applied
- The sample is e.g. very viscous and runs through the test strip very slowly.
Background: No sample application was detected within the defined time.
Step Action
1 Insert a new test strip and repeat the test
2 Was precisely 150 µL of sample applied?
3 Repeat the test with a new test strip from another lot.
4 Was the blood soaked up completely or is an inhomogeneous sample flow visible on the test pad of the strip?
5 Did the sample match the criteria defined in the package insert (i.e. Icterus (bilirubin), Hemolysis, Lipemia
(triglycerides), Hematocrit values?
If the complaint persist request the strips for inspection
Number
Back
E-405
A measurement error occurred. Check your procedure and

repeat test, using a new test strip.
Introduction:
This error message can be related to many different failure sources, such as.
- Application failure,
- Strip failure,
- Mishandling,
- Interferences in the sample,
- For instruments serial number < KQ0120000 and < KS0210000), a damaged images sensor (Purple Plaque).
Time:
The root cause for the error message has to be seen in a timely manner of its appearance during a measurement. Good
information about the appearance of the failure will help to classify it correctly and to carry out the correct actions.
The later the error appears, the higher the chance for sample failure or interferences.
An instrument can release an error:
A: During boot sequence and instrument self- test
B: When a strip is inserted
C: When the sample was applied and instrument is warming up
D: Approx. 5 minutes or later after begin of the measurement
General Remarks Sample Preparation:
Heparinized venous whole blood is used as sample material. For each test with the cobas h 232 meter, you need a
quantity of exactly 150 µL.
Tubes:
There are color codes for tubes but the color of the tube's plastic cap is not always standardized across manufacturers. In
all case refer to the package inserts for the information regarding the usage of tubes. All tubes listed there have been
evaluated and might be used without problems.
Note:
Using the wrong tube will make the blood sample unusable.
Storage:
Sample must not be centrifuged
Sample Application:
Mechanical action pipettes require a relatively high level of care to ensure they are always functioning correctly. Corrosion or
leaking within the pipette can occur and these failures are not easily detectable by the user, so incorrect volumes can be
applied.
collection vial.
Make sure the sample contains no air bubbles. Apply the entire sample to the application area of the test strip.
Always place the meter on a level, vibration-free surface while applying the sample until the necessary
sample has been absorbed completely by the test strip.
The pipette should be held in a vertical position to avoid spilling of the blood sample. Also, do not touch the test strip with the
pipette and assure that the needle does not penetrate the strip.
After the measurement

Remove the test strip from the instrument.
- Dispose of the test strip according to local guidelines

- Dispose used pipettes and test strips in a sturdy sharps container with a lid.
- Discard used disposable items and strip in compliance with the disposal policy of your hospital or medical practice.
For information about correct disposal please contact your local council or authority.
Furthermore, follow all hygiene and safety regulations in force locally.
A: The error appears during the boot sequence and instrument self-test
Possible cause:
• Foreign light was detected
• Purple Plaque Failure (for instruments serial number < KQ0120000 and < KS0210000),
Step Action
1 Perform a failure free boot sequence
2 If the error persists through five reboots of the instrument request the cobas h 232 for inspection

Number
(instrument)
Back
B: The error appears when a strip is inserted
Possible cause:
• Strip barcode defective, scratched
• Application failure
• Mishandling
Step Action
1 Inspect backside of strip visually and notice scratches or damages on the strip.
If the barcode appears to be clean and undamaged, restart instrument and perform a failure free boot sequence and
2 Repeat with another strip from the same lot
If the error persists request the cobas h 232 and the used strips for inspection
Number
Back
C: The error appears when the sample was applied and the instrument is warming up (< 5 min after sample
application)
Possible cause:
• Strip damaged, control line interrupted (see also picture gallery),
• Interferences from sample,
• Overdosing (see also picture gallery),
• Wrong heparinization of the sample, wrong tubes (refer to package insert),
• Handling (preparation, pipetting, etc.).
the sample is flowing along the strip, the background color of the test field will change and the control line is building up.
If, due to a pre-analytic failure, the sample will not flow or not flow correctly, the line cannot be detected and the
instrument aborts the measurement with an error message. Also interferences of the sample can cause the line to
disappear.
Step Action
1 Check the used sample tubes against the information provided in the package insert (no separation gel, no
EDTA), was the correct Heparin type used? Are Roche Cardiac Pipettes used?
Repeat the measurement with another strip from the same lot.
2 Does the failure appear always with the same patient? Check medical history and drug list against information from
the package inserts
Repeat the measurement with another strip from another lot.

3 Repeat with another strip from the same lot
If the error persists request the strips for inspection

Number
Back
D: The error appears >5 minutes after sample application
Possible cause:
If the measurement is aborted at this time, there is a very high chance that interferences in the sample have caused the
control line to disappear.
High dose hook effect should be taken in consideration
Background:

When collecting samples always observe the general precautions and guidelines related to blood
sampling.
A visual inspection of the strip can provide information, too. If possible, (or if needed) the strips cover can be opened to
investigate the strip visually for the following effects:
• Background of test field too reddish, line not visible anymore.
• Too much of the sample applied
• Flow of the sample along the strip
• Damages of the strips material
Note: Another hint for possible interferences can be the fact that a sample measurement of one very same patient is
always aborted while samples from other patients can be measured on the very same meter without any interruption or
problems. Medical history and drugs applied to the patient should be taken in consideration first when trying to find the real
root cause for the interferences. The package insert lists all known sources for such interference.
High Dose Hook Effect

The High Dose Hook Effect appears as an artifact on some of the Roche Cardiac assays, which causes the reported
quantity of the marker to be falsely low when the quantity is high.
Reason for that is the disappearance of control line due to high amount of particles binding the antibodies. Finally there are
no free antibodies to form the line or antibodies are washed out from an already formed line. The instruments camera
notices the disappearance of the former existing control line; the instrument aborts the measurement and releases an error
instead.
Step Action
1 Check the used sample tubes against the information provided in the package insert (no separation gel, no
EDTA), was the correct Heparin type used? Are Roche Cardiac Pipettes used?
Repeat the measurement with another strip from the same lot.
2 Repeat the measurement with another strip from another lot.

If the failure persists ask for a patient sample to be investigated in Mannheim.
Obtain further information and instructions prior to the shipment of the sample.
Number
Patient Sample
Preanalytics / Sample Handling
Back
6.7 Error Messages – Category: Self-Check Errors
E-501
The self-test detected a general error. Repeat the self-test.

Restart meter, if the problem persists.
Possible cause: Self-test error
Background:
Step Action
1 Reboot the instrument

Number
(instrument)
Back
E-502
The self-test cannot be performed when a strip is inserted.

Remove the test strip and repeat the self-test.
Possible cause: Strip inserted during self-test
Background:
Step Action
1 Remove the test strip and reboot the instrument. Ensure that a failure free boot sequence was carried out before a
measurement is started

- Wait 10 seconds
- Repeat the test.
3 Request the cobas h 232 for inspection
Number
/ Handling
Back
E-503
The self-check detected a camera error. Remove the

meter from direct bright light and repeat self-check.
Possible cause: Camera error or ambient light too bright.
Background:
Step Action
1 Remove the meter from direct bright light and repeat a self-test

Number
(instrument)
Back
E-504
The self-test detected a barcode reader error. Remove the

meter from direct bright light and repeat self-test.
Possible cause: The self-test detected a barcode reader error
Background:
Step Action
1 Remove the meter from direct bright light and repeat a self-test

Number
(instrument)
Back
6.8 Error Messages – Category: System Errors
E-601
Code chip cannot be read.

Remove the code chip and restart the test.
Possible cause: The code chip is missing or cannot be read

- Often handling failure or a drop of the instrument can lead to a damage code chip slot. The above-mentioned error
code will be released than.
- The code chip slot can also be damaged if the code chip was forced in upside down
Background:
Note:
When using a new strip lot AND a new Quality Control (QC) lot at the very same time.
Both code chips have to be inserted after each other or the error message persists in all cases.
Step Action
1 Insert the missing code chip corresponding to the test strip into the meter. When inserting the code chip, make
sure that the labeling faces upwards. Test strip and code chip must have the same lot number.
2 Insert and remove the code chip several times.
3 Clean the contacts on the reverse side of the code chip. Re-insert the code chip
4 Send the customer a new code chip of the same test strip lot, or exchange the test strip package if necessary.
Number
Back
E-602
General system error. The meter is defective.

No test is possible.
Contact your Roche representative.
Possible cause: General system error
Background:
Do not operate the meter near strong high-frequency transmitters (e.g. mobile phones).
Step Action
- Wait 10 seconds
- Repeat the test.
Number
(instrument)
Back
E-603
Temperature or heater error.

Turn the meter off and on, and repeat the last procedure.
If the error persists, contact your Roche representative.
Possible cause: Heater error
Background:
The internal heater might be defective or damaged
Failure can also appear if strips are used directly from the fridge. Work-around: If such an error message is displayed when
very cold strips are used, update the meter to SW Version 04.00.01 or higher
Step Action
- Wait 10 seconds
- Repeat the test.
Number
(instrument)
Back
E-604
Camera error.
Possible cause:
• Internal camera defective
• Failure can be released from the instrument after a battery low warning (E-302). It is necessary to ensure that the
instrument is operated with a fully loaded handheld battery pack or with a handheld power supply connected
Background: The internal camera might be defective or damaged
Step Action
- Wait 10 seconds
- Repeat the test.
Number
(instrument)
Back
E-605
Hardware or electronic error. Turn the meter off and on, and
repeat the last procedure. If the error persists, contact your
Roche representative.
Possible cause:
• Hardware or electronic error
Background: The hardware or an electronically component might be defective or damaged
Step Action
- Wait 10 seconds
- Repeat the test.
Number
(instrument)
Back
E-606
Measurement sequence error. Turn the meter off and on,

and repeat the last procedure. If the error persists, contact
your Roche representative.
Possible cause:
• Measurement sequence error
Background: An error did occur during the sequence of the measurement.
Step Action
- Wait 10 seconds
- Repeat the test.
Number
(instrument)
Back
E-607
Error with measurement module. Turn the meter off and on,
Possible cause:
• An error on the measurement module was detected
Background: An error on the measurement module was detected
Step Action
- Wait 10 seconds
- Repeat the test.
Number
(instrument)
Back
E-608
A software error was detected. Turn the meter off and on,
Possible cause:
• A software error was detected
Background:
Note: E-608 may occur after the update. It is not failure; data has been cleared during the update.
If the error persists in such a case after a complete reboot as defined underneath the meter should be requested for
inspection
Step Action
- Wait 10 seconds
- Repeat the test.
Number
Software failure Software Failure
Back
6.9 Error Messages – Category: Communication Errors
E-701
Connecting the host system failed. Remove the meter from

the Base Unit and put it back. If the error persists, turn the
meter off and on.
Possible cause: Connection failure to host
Background:
Step Action
1 Remove the meter from the handheld base unit and put it back.
2 Switch the cobas h 232 off and on again
3 Put the cobas h 232 back to the handheld base unit.

If the complaint persists continue with “Handheld Platform Connectivity Trouble Shooting Guide” on connectivity
issues.
If the problem cannot be solved, request the cobas h 232 and/or handheld base unit for inspection

Number
Back
E-702
A communication error with the host system occurred.

Remove the meter from the Base Unit and put it back. If the
error persists, turn the meter off and on.
Background:
Step Action
1 Remove the meter from the handheld base unit and put it back.
2 Switch the cobas h 232 off and on again
3 Put the cobas h 232 back to the handheld base unit.

issues.

Number
Software failure Other / Unknown
Back
E-703
Communication with printer failed. Check the position of

meter and printer. If the error persists, turn the meter and
printer off and on
Possible cause: Communication with printer failed
Background:
Only the printer Citizen CMP-10 is recommended for the use with the cobas h 232 system. Other printer
types may not communicate with the cobas h 232 system.
Check whether the infrared windows of the meter and the printer are facing each other and ensure that the distance
between them is not too great.
The two infrared windows must be 10 - 50 cm apart and facing one another. Neither must point away from
the other by more than 15% (to the left or tight). There must not be any objects obstructing “line-of-sight”.
Check the set up settings in the software.

If the „Connection“-setting OFF is activated, change it to Computer for Host communication or Printer - for printing
Step Action
1 Increase the distance from the light source
2 Restart the print job
3 Check if the printer is switched on and that the printer battery is charged.
If the complaint persist request the cobas h 232 and the printer for inspection
Number
Back
E-704
An ICI communication error with the host system occurred.

If the error persists, turn the meter off and on and repeat
the last procedure
Possible cause: ICI communication error
Background:
Communication with host system failed.
An Error 704 can also be an indicator for a defective base unit.
Step Action
1 Remove the meter from the handheld base unit and put it back

- Wait 10 seconds
- Repeat the test.
issues.
Number
Back
E-705
An internal communication error with the measurement

module did occur.
Possible cause:
• Connection to the measurement module is interrupted.
instrument is operated with a fully loaded handheld battery pack or with a handheld power supply connected.
Other reasons for this error:

In rare cases a hardware defect or defects on the electronic parts of the measurement module were observed. In such a case
the error E-705 will persist also after a software update.
Background:
Before performing a measurement ensure that the boot sequence was carried out without any failure.
Refer to Service Bulletin No 41.

If the error is related to a software error it can most likely be solved with a software update.
Step Action
- Wait 10 seconds
- Repeat the test.
Category Code Cause Code FLIU Code Error Number
(instrument)
Back
E-706
An internal communication error with the barcode reader

module occurred.
Possible cause: Internal communication error with the barcode reader
Background:
Step Action
- Wait 10 seconds
- Repeat the test.

Number
(instrument)
Back
E-707
An internal communication error with the barcode scanner

module occurred. Turn the meter off and on, and repeat the
last procedure. If the error persists, contact your Roche
representative.
Possible cause: internal communication error with the barcode scanner
Background:
Step Action
- Wait 10 seconds
- Repeat the test.

Number
(instrument)
Back
E-708
A general communication error has occurred. Turn the

meter off and on, and repeat the last procedure. If the error
persists, contact your Roche representative
Possible cause: A general communication error has occurred
Background:
Step Action
- Wait 10 seconds
- Repeat the test.

Number
(instrument)
Back
6.10 Error Messages – Category: Database Errors
E-801
The meter database cannot be read and will be deleted.

Turn the meter off and on. If the error persists, contact your
Roche representative
Possible cause: Meter database cannot be read
Background:
Step Action
- Wait 10 seconds
- Repeat the test.
If the complaint persists request the cobas h 232 for inspection
Number
Software failure Software Failure
Back
E-805
The meter detected a fault with the EEPROM memory.

Turn the meter off and on. If the error persists, contact your
Possible cause: EEPROM memory cannot be read
Background:
Step Action
- Wait 10 seconds
- Repeat the test.

Number
(instrument)
Back
E-806
The meter detected a fault with the flash memory. Turn the
meter off and on. If the error persists, contact your Roche
representative.
Possible cause: Flash memory cannot be read
Background:
Step Action
- Wait 10 seconds
- Repeat the test.

Number
Back
E-807
The meter detected a general fault with the memory. Turn

the meter off and on. If the error persists, contact your
Possible cause: General memory error
Background:
Note: E 807 may occur after the update. It is not failure; data has been cleared during the update.
If the error persists after the device was turn off and on again, the device is possibly defective and should be send for
investigation
Step Action
- Wait 10 seconds
- Repeat the test.
Number
(instrument)
Back
7. Errors without displayed Messages
7.1 Error in Documentation
Problem
• Error in Operator Manual Provide detailed error description with exact page reference,
• Error in instruction leaflet and manual version number.
• Error in package insert Provide also a copy or screenshot of detected failure

Number
Labeling / Documentation Operator's Manual
Back
7.2 Partial defectiveor faulty Display
A display error does not affect the measuring performance of the instrument.
In order that errors may be excluded in result interpretation, the meter should be requested for
inspection in any case of a faulty display.
PCC Guidelines have to be obeyed in all cases
Problem Action:
Digits, letters ore symbols are displayed incompletely or Switch the cobas h 232 off.
incorrectly. - Unplug the handheld power supply.
- Wait 10 seconds
- Fit a fully loaded handheld battery pack back into the
cobas h 232.
- Repeat the test.
If the complaint persists request the cobas h 232 for

inspection

Number
User Interface (Display / Electronic Failure
Touch)
Back
7.3 Sound not working
The functioning of the sound does not affect the measuring performance of the instrument.
Problem Action:
The sound (beeper) is not working Switch the cobas h 232 off.
- Wait 10 seconds
- Fit a fully loaded handheld battery pack back into the
cobas h 232.
- Repeat the test.
If the complaint persist continue with the next step
Check the METER SETUP settings whether the SOUND is

activated.
If the complaint persists request the cobas h 232 for

inspection

Number
(instrument)
Back
7.3 Visible Meter Defects
Problem Action:
Upper or lower part of case damaged If the upper or lower part of the case is damaged request
the cobas h 232 for inspection

Number
Chassis, Housing Damaged
Back
7.4 Missing or Faulty Part
Problem Action:
Parts missing. If one of the parts listed opposite is missing or faulty upon
delivery, supply missing part to customer.
The cobas h 232 supply packages consist of:

- cobas h 232 meter
- External handheld power supply with cable
- Operator’s manual
- CD-ROM with Operator’s manual in other languages

Number
Packaging: Missing Item Component missing
Back
7.5 Meter freezing during connection to DMS
Problem Description Action:
Instrument is freezing while docked on handheld base unit The following actions must be carried out during trouble
and connected to a DMS. shooting in order to solve the problem:
Instrument must be undocked and Handheld Battery Pack - Update the instrument to the latest software version
must be removed in order to restart the instrument. - Update of the handheld base unit to the latest software
version
- Ensure that the length of the operator list uploaded to
the instrument does not exceed the maximum amount
of operators which can be stored on the instrument
(refer also to the Operator Manual).
- Ensure that operator certificates do not have an
expiration date beyond 2047 (see PB 2012/013)
Hardware related issue:

One issue with a defect on the charging electronics of the
meter was reported which led to a similar behavior of the
meter.
For testing purposes the instrument can be operated on

HBU without a handheld battery pack inserted.
If the error persists after the above-mentioned actions have

been carried out and a hardware related issue is expected,
the instrument must be requested for inspection.
Reference: refer also to QN-CPS-2016-155

Number
(instrument)
8. Error with samples
8.1 Sample Collection Errors
Background: The sample material must be (lithium or ammonium) heparinized venous whole blood. Other anticoagulants
are not allowed. Plasma, serum or capillary blood must not be used. Do not use collection tubes containing gel, EDTA,
sodium fluoride or citrate. With EDTA blood, serum, or heparinized and EDTA plasma results are about 30 % -50 % lower.
The maximum permissible sample age is 8 hours. The sample must neither be refrigerated nor frozen. The test strip must
be used within 15 minutes once its foil pouch has been opened.
Use of CARDIAC Pipettes:

Use CARDIAC Pipettes to transfer blood from a stoppered sample collection tube to test strip. First press plunger fully home,
and then pierce rubber membrane of the stoppered sample collection tube with needle. Always ensure that the blood is
properly homogenized before you transfer it to the test strip. Invert the tube repeatedly before withdrawing blood. Turn tube
upside down and draw blood to the 150 μl mark. Hold the stopper firmly when withdrawing the needle. Be sure to draw up the
correct volume (no air bubbles pipette properly filled to the 150 µl mark).
Under dosage may result in falsely low and over dosage in falsely elevated values. With very pronounced over dosage, a
decrease of values has been observed in some cases. W ith extreme under dosage the sample does not reach the
detection area and no control line appears. The measurement will be aborted.
Never use CARDIAC Pipettes to collect blood directly from a vein, nor for administering injections! They are
not sterile-packaged; nor do they contain anticoagulant.
Questions to be asked in case of suspected application failure
Questions to be asked in case of suspected application failure

1 Has venous blood been collected as a sample?
2 Has a heparinized collection tube been used for sample collection which is listed in the package insert?
3 Did the collection tube contain sodium fluorite?
4 Has the measurement been done with whole blood?
5 Has the measurement been done within 8 hours after sample collection?
6 Was the sample frozen before the measurement?
7 Was the sample refrigerated before the measurement?
8 Has the measurement been done within 15 minutes after opening the test strip foil pouch?
9 Was the sample volume exactly 150 µl?
For applying blood to the test strip: use CARDIAC Pipettes, available separately (recommended), or any
laboratory pipette with a volume of 150 μl. Most laboratory pipettes only allow pressing as far as the first
stop when aspirating the volume. Normal injection syringes are too inaccurate for dosing the sample
volume.
10 When using CARDIAC Pipettes, has the sample been drawn up and expelled several times?
The plunger may be drawn up only once. Drawing up and expelling the sample several times is
not allowed.
11 Did the sample contain air bubbles?
12 Was the blood properly homogenized before you transferred it to the test strip?
If the sample is not sufficiently homogenized, the plasma separates from the solid blood
constituents. If material is pipetted from the plasma (in the upper part of the collection tube), no
interference is observed up to hematocrit values of 30 %. If material is pipetted from the lower
part of the collection tube, no interference is observed up to hematocrit values of 52 %. The
influence of higher hematocrit values is not known.
13 Has the pipette or syringe been kept vertical when applying sample on to the application area of the strip?
14 Has the application area been touched while applying sample?

Number
8.2 Measurement does not start
Background:
laboratory pipette with a volume of 150 μl. When using CARDIAC
Pipettes make sure that the meniscus is located exactly between the two marks. Normal injection syringes
are too inaccurate for dosing the sample volume.
With very pronounced under dosage (< 100 μL) the sample does not reach the detection area, and no
control line appears. (Refer also to the Picture Gallery)
Questions to be asked in case that the measurement does not start
Step Questions to be asked in case that the measurement does not start
With very pronounced under dosage (< 100 μL) the sample does not reach the detection area,
and no control line appears.
2 Was the lot-specific code key supplied with the test strip package used?
3 Was the barcode on the underside of the test strip scratched?
4 Repeat the test with a new test strip!

If the problem persists, continue with step 5
5 Repeat test with a new lot of test strips!

If the complaint persist request the cobas h 232 and the strips for inspection

Number
8.3 Values are not reproducible
Background:
Change between different sample materials:

Recovery is different for different sample materials. When changing between different sample materials, values cannot be
reproduced.
Note:
Whenever non-reproducible measuring results occur, this might suggest customer interference
Therefore, go on with: Sample Collection Errors
8.4 Errors in Reconstituting Control Solution
Background:
Allow liquid Quality Controls stored at temperatures of between +2 °C (36 °F) and +8 °C (46 °F) to reach room
temperature prior to use, in conformity with the instructions for use. CARDIAC control CK-MB Quality Controls must not be
used after the printed expiry date. Carefully open the bottle, avoiding the loss of lyophilizate, and pipette in exactly 1.0 ml
distilled water. Carefully close the bottle and dissolve the contents completely by occasional gentle swirling within 15
minutes. Avoid the formation of foam.
laboratory pipette with a volume of 150 μl. When using CARDIAC Pipettes make sure that the meniscus is
located exactly between the two marks. Normal injection syringes are too inaccurate for dosing the sample
volume.
With very pronounced under dosage (< 100 μL) the sample does not reach the detection area, and no
control line appears. (Refer also to the Picture Gallery)
Questions to be asked in case that the liquid control cannot be used correctly.
Step Questions to be asked in case that the liquid control cannot be used correctly
1 Has the control solution been stored at a temperature of between +2 °C (36 °F) and +8 °C (46 °F)?
2 Was the expiry date of the control solution exceeded?
3 Has the liquid Quality Control package been allowed to reach room temperature before use, in conformity with the
instructions for use?
4 Has loss of lyophilizate been avoided when opening the liquid Quality Control?
5 Has distilled water been used for dissolving the lyophilizate?
No studies have been made for physiological saline solutions.
6 Has exactly 1.0ml of distilled water been used for dissolving the lyophilizate?
7 Has the control bottle been agitated or tipped over during reconstitution?
Dissolve the contents completely by occasional gentle swirling. Avoid the formation of foam.
8 Have frothing and bubbles been avoided during reconstitution?
9 Has the Control lyophilizate been completely dissolved within 15 minutes?
10 Has the liquid Quality Control been mixed well before testing?
If all of the above questions could not lead to a sufficient solution, the handling seems to be OK.
Go on with:
“Liquid Quality Control Test outside the Control Range” for the specific parameter

Number
9. Questionable Results with Blood
Quick access to parameter
In case of implausible test results with blood, verify which Which parameter was used for testing?
parameter was used for testing
CARDIAC T Quantitative
CARDIAC Myoglobin
CARDIAC D-Dimer
CARDIAC pro BNP
CARDIAC CK-MB
CARDIAC POC Troponin T
9.1 CARDIAC T Quantitative
9.1.1 Values too low compared to laboratory method
Problem:
Values too low compared to laboratory method
Possible cause: Application failure, Interferences
Note that a comparison should best be done with Elecsys Troponin T as the other lab method might not be standardized.
Background:
Normally, Troponin T first starts to be released into the blood 2 to 8 hours after myocardial damage has occurred, though it
sometimes starts later. CARDIAC T Quantitative thus has a diagnostic window that extends from 2 hours to 14 days
CK-, CK-MB and Troponin I release do not occur simultaneously with Troponin T release
Target values are lot specific
Step Action
1 Is the sample within the defined limits from the package insert (triglyceride, Lipemia, etc.) and was the measurement
performed within the right temperature range and within the defined time period after onset of symptoms?
2 Discuss handling, used sample collection tubes, pipettes and application. Can handling, sample collection tubes,
pipettes and application failure be clearly excluded as a failure source?
If the complaint persists continue with step 3
3 Has a liquid Quality Control test been successfully performed?


5 Repeat test with a new lot of test strips

If the complaint persists request previous lots of test strips and liquid Quality Control (package) for inspection

Number
Questionable results Method Comparison
9.1.2 Values too high compared to laboratory method
Problem:
Values too high compared to laboratory method
Possible cause: Interferences, contamination of the optical system
Note that a comparison should best be done with Elecsys Troponin T as the other lab method might not be standardized.
Background: Normally, Troponin T first starts to be released into the blood 2 to 8 hours after myocardial damage has
occurred, though it sometimes starts later. CARDIAC POC Troponin T thus has a diagnostic window that extends from 2
hours to 14 days. Skeletal muscle Troponin T of up to 500 ng/ml leads to a maximum increase of +10 %, at 1000 ng/ml the
increase may reach 30 %. Such very high skeletal muscle Troponin T concentrations only occur in very severe muscle
diseases (e.g. rhabdomyolysis, polymyositis) and/ or muscle injuries, which cannot be overlooked clinically.
As with all tests containing mouse antibodies, erroneous findings may be obtained from samples taken from patients who
have been treated with monoclonal mouse antibodies or have received them for diagnostic purposes. CARDIAC POC
Troponin T contains additives which are to prevent these effects. In some cases though, interferences due to extremely high
titers of antibodies can occur
All Cardiac tests are protected against interference from common heterophilic antibodies (interference
filter MAK33). Patients who have been in contact with animals or have been treated with certain
medications containing monoclonal antibodies can develop new types of heterophilic antibodies against
interference from which the Cardiac tests are not protected. This can lead to falsely elevated or positive
values.
Step Action
1 Has the patient been treated with medications containing monoclonal mouse antibodies, or
have they been administered for diagnostic purposes?
2 Discuss handling, used sample collection tubes, pipettes and application. Can handling,
sample collection tubes, pipettes and application failure be clearly excluded as a failure
source?
If the complaint persists request previous lots of test strips and liquid Quality Control (package)
for inspection

Number
9.1.3 Compared to patient data (history/ diagnosis/ treatment) the values are too high
Problem:
Compared to patient data values are too high
Possible cause:
Background: Normally, Troponin T first starts to be released into the blood 2 to 8 hours after myocardial damage has occurred,
though it sometimes starts later. CARDIAC POC Troponin T thus has a diagnostic window that extends from 2 hours to 14
days. Skeletal muscle Troponin T of up to 500 ng/ml leads to a maximum increase of +10 %, at 1000 ng/ml the increase may
reach 30 %. In very severe muscle diseases (e.g. rhabdomyolysis, polymyositis) and/or injuries the 0.01 % cross- reactivity
can lead to falsely positive values.
Step Action
1 Has a comparison with an ECG been made?
2 Has myocardial damage been detected?
3 Has renal failure been detected without acute coronary syndrome being diagnosed?
4 Has a very severe muscle disease (rhabdomyolysis, polymyositis) been detected?
5 Has a very severe muscle injury been detected?

Number
Questionable results Other / Unknown
9.1.4 Compared to patient data (history/ diagnosis/ treatment) the values are too low
Problem:
Compared to patient data values are too low
Possible cause:
days.
Step Action

Number
9.1.5 Liquid Quality Control Test outside the Control Range
Problem:
Liquid Quality Control Test outside the Control Range
Possible cause:
Background:
This p r o d u c t has b e e n p r e p a r e d exclusively from the blood of donors tested individually and found by
FDA approved methods to be free from HBsAg and antibodies to HIV and HCV. However, as no testing method
can rule out the risk of potential infection with absolute certainty, the product must be handled just as carefully
as a patient specimen. In the event of exposure, the directives of the responsible health authorities should be
followed.
Disposal of waste material should be in accordance with local guidelines.
Allow liquid Quality Control stored at temperatures of between +2 °C (36 °F) and +8 °C (46 °F) to reach room temperature prior
to use, in conformity with the instructions for use. CARDIAC control Troponin T Quality Controls must not be used after the
printed expiry date. Maximum stability of components in reconstituted control serum at:
18 °C - 25 °C (64 °F - 77 °F) 24 hours

2 °C - 8 °C (36 °F - 46 °F) 3 days
-20 °C (-4 °F) 8 weeks (can be frozen up to 4 times in the original bottle)
For applying the liquid Quality Control to the test strip: use CARDIAC Pipettes, available separately (recommended), or any
laboratory pipette with a volume of 150 μl. Most laboratory pipettes only allow pressing as far as the first stop when
aspirating the volume. Normal injection syringes are too inaccurate for dosing the sample volume.
The control range is lot-specific
Step Action
1 Has the Control Solution been properly reconstituted?
2 Was the expiry date of the control solution exceeded after reconstitution?
3 Has the right liquid Quality Control been used?
4 Has the liquid Quality Control been allowed to reach room temperature prior to use?
5 Has the liquid Quality Control test been performed at a room temperature of 18 °C (64 °F)?
9 Has a new (unused) pipette tip been used for testing?
10 Repeat liquid Quality Control test
11 Repeat liquid Quality Control test with new Control lot
If the complaint persists request test strips (package) and both liquid Quality Control lots (packages) for
inspection

Number
9.1.6 Difficulties to compare Troponin T values with Troponin I values
Bases on the latest experiences and received information it is necessary to inform the affiliates about the difficulties
comparing Troponin T values with Troponin I values and to highlight the available documentation and material on this
subject.
Due to different reasons values from Trop T cannot be compared with values from Trop I directly.
Troponin T and Troponin I are different enzymes. While the measurement of Troponin T is highly standardized, the
measurement of Troponin I is not standardized and will therefore vary between manufacturers, assays and measurement
methods.
Refer also to the Cardiac product knowledge base which was updated for this subject recently.
Find here some important excerpts from the Cardiac product knowledge base / Cardiac Toolkit to outline this issue.
Excerpt from CTK 2013 – Cardiac biomarker manual, V1
Cardiac troponin T (cTnT) and I (cTnI)

Troponin is a 3-unit protein complex that has a role in regulating calcium-triggered muscle contraction (62). The cardiac
specific isoforms, cTnT and cTnI, have nearly absolute myocardial tissue specificity and high clinical sensitivity for
myocardial necrosis (6).
cTnT and cTnI are used in detection of myocardial cell injury (63) and are the preferred markers for the diagnosis of MI
(23). Guidelines recommend measurement of rise and/or fall of cardiac biomarkers in addition to ECG for a definitive
diagnosis (6,12,13,15,64).
Cardiac troponins are helpful in identifying patients with acute coronary syndrome (ACS) who are at high risk of death (12)
and are useful for selecting patients who will benefit from an early invasive strategy and glycoprotein IIb/IIIa blockade
(25,26).
cTnT and cTnI differ in some important aspects with respect to their use in MI diagnosis. cTnT is more stable than cTnI
(65) and has a higher predictive value for 30-day mortality in ACS patients than cTnI (66). Its levels at 72 hours after the
onset of symptoms or admission significantly correlate with infarct size (18), whereas the value of cTnI in this setting is not
known.
With respect to troponin assays, all assays for cTnT are offered by only one manufacturer and are all calibrated to the
same reference material (63). cTnI assays are offered by a variety of companies, with differences in calibration, antibodies
and cut-off values (67), making it difficult to compare results obtained with different assays.
References
6 Thygesen et al (2007). Circulation 116:2634-2653.

12 Hamm et al (2011). Eur Heart J 32:2999-3054
13 Van de Werf et al (2008). Eur Heart J 29:2909-2945
15 Morrow et al (2007). Clin Chem 53:552-574
18 Licka et al (2002). Heart 87:520-524
23 Sim et al (2008). Biomark Insights 3:293-302

25 Newby et al (2001). Circulation 103:2891-2896
26 Morrow et al (2001). JAMA 286:2405-2412
62 Babuin & Jaffe (2005). CMAJ 173:1191-1202
63 Wu et al (1998). Clin Chem 44:1198-1208
64 National Institute for Health and Clinical Excellence. Chest pain of recent onset - Clinical guideline 95. 2010.
Available at http://guidance.nice.org.uk/CG95/NICEGuidance/pdf/English. Last accessed August 2012.
65 Labugger et al (2000). Circulation 102:1221-1226
66 Christenson et al (1998). Clin Chem 44:494-501
67 Tate et al (2010). Pathology 42:402-408
Excerpt from Cardiac biomarkers at the point of need, Version 3 – May 2013
Reasons why cTnT is a better biomarker for MI than cTnI

1
cTnT assays are calibrated to the same reference material , allowing comparable results
1 2–3
between POC and lab, whereas difficulties exist with cTnI assay standardization
4
2 cTnT has a greater ability to predict 30-day mortality than cTnI
5
3 cTnT is elevated in a higher percentage of ESRD patients than cTnI
6
4 cTnT has demonstrated value for detecting infarct severity during acute MI , whereas no
evidence of this value exists for cTnI
cTnT produces fewer degradation products and is less susceptible to phosphorylation than
5 7
cTnI
Rationale:
• Both markers have a role in cardiac muscle contraction (cTnT attaches the troponin complex to
8
tropomyosin and cTnI inhibits actin-myosin interaction in absence of calcium)
1
• All commercial cTnT assays are available from a single manufacturer whereas cTnI assays
2,3
are offered by several companies
5
• Serum levels of cTnT are elevated in 82% of ESRD patients vs. 6% with cTnI
• Significant correlation between single cTnT measurement taken at 72 hours after onset of chest
6
pain or admission and infarct size
• N- and C-terminals of cTnI are highly susceptible to proteolysis and enzymatic modification. In
vitro stability of assay is method dependent. Various plasma forms also undergo oxidation,
2,3,7
reduction phosphorylation and dephosphorylation
References
1. Wu et al (1998). Clin Chem 44:1198–1208
2. Panteghini et al (2008). Clin Chem Lab Med 46:1501–1506
3. Tate et al (2010). Pathology 42:402–408
4. Christenson et al (1998). Clin Chem 44:494–501
5. Apple et al (2002). Circulation 106:2941–2945
6. Licka et al (2002). Heart 87:520–524
7. Labugger et al (2000). Circulation 102:1221–1226
8. Baker et al (2011). Heart 97:447–452
The Cardiac Toolkit is available from the RPD Homepage.
Link: http://rpd-pkb.dia.roche.com/Pages/DXP/dxph_cardiac-systems_cobas-h-232.aspx#tab-marketingMaterials
As it is not possible to compare results obtained with different assays, escalation of such cases via the global complaint
handling system is not needed.
9.2 CARDIAC Myoglobin
Problem:
Note that a comparison should best be done with Elecsys Myoglobin as the other lab method might not be standardized.
Background:
The Roche CARDIAC M test serves as an aid in diagnosis when myocardial infarction is suspected and in reperfusion
control. Myocardial infarction can be ruled out if the myoglobin result is negative 6 to 10 hours after a cardiac event.
Myoglobin is released into the blood 2 to 3 hours after the onset of myocardial infarction. The Roche CARDIAC M test has a
diagnostic window of 2 to 12 hours. Myoglobin is a muscle protein which is released when damage is sustained by the cells
of the myocardium and the skeletal muscle. Immunologically, there is no difference between proteins from the myocardium
and skeletal muscle. Consequently, cardiac myoglobin, unlike cardiac troponin T, cannot be measured specifically.
Patient samples may contain heterophilic antibodies which could react in immunoassays to give falsely elevated or
decreased results. Reasons for the presence of heterophilic antibodies might be for example elevated levels of rheumatoid factors
or the treatment of patients with monoclonal mouse antibodies for therapeutic or diagnostic purposes. The Roche CARDIAC M
test contains ingredients that minimize interference from heterophilic antibodies. However, complete elimination of
interference from all samples cannot be guaranteed. Interferences caused by pharmaceuticals at therapeutic
concentrations are not known.
Step Action

Number
CARDIAC Myoglobin
Problem:
Possible cause: Interferences, contamination of the optical system,
Note that a comparison should best be done with Elecsys Myoglobin as the other lab method might not be standardized.
Background: Patient samples may contain heterophilic antibodies which could react in immunoassays to give falsely
elevated or decreased results. Reasons for the presence of heterophilic antibodies might be for example elevated levels of
rheumatoid factors or the treatment of patients with monoclonal mouse antibodies for therapeutic or diagnostic purposes. The
Roche CARDIAC M test contains ingredients that minimize interference from heterophilic antibodies.
However, complete elimination of interference from all samples cannot be guaranteed.
Interferences caused by pharmaceuticals at therapeutic concentrations are not known.
values.
Step Action
1 Has the patient been treated with medications containing monoclonal mouse antibodies, or have they been
administered for diagnostic purposes?


Number
CARDIAC Myoglobin
Problem:
Possible cause:
Background: Myoglobin may be elevated from conditions other than acute myocardial infarction as other cardiovascular
diseases.
Step Action
2 Has certain cardiovascular diseases been diagnosed?
3 Has surgical procedures been performed with the patient?

Number
CARDIAC Myoglobin
Problem:
Possible cause:
days.
Step Action


Number
CARDIAC Myoglobin
Problem:
Possible cause:
Background:
followed.
to use, in conformity with the instructions for use. CARDIAC Myoglobin Quality Controls must not be used after the printed
expiry date. Maximum stability of components in reconstituted control serum at:
18 °C - 25 °C (64 °F - 77 °F) 24 hours

Step Action
inspection

Number
9.3 CARDIAC D-Dimer
Problem:
Note that a comparison should best be done with Tina-quant D-Dimer as the other lab method might not be standardized.
Background: Test in the case of suspected deep venous thrombosis and pulmonary embolism. Can be ruled out with a very
high degree of probability if the result is negative.
High concentrations of D-Dimer (approx. > 50 µg/ml) can lead to the measurement of lowered values (Hook
effect). However, this effect does not lead to the measurement of falsely normal values.
D-Dimer is not a homogeneous and clearly defined analyte. The antibodies of the D-Dimer tests react
differently with the spectrum of the fibrin fission products. The different binding characteristics of the
antibodies result in sample-specific differences compared to D-Dimer methods other than Tina-quant D-
Dimer.
High concentrations of D-Dimer (approx. > 50 μg/ml) can lead to the measurement of lowered values (Hook
effect). However, this effect does not lead to the measurement of falsely normal values.
At 18 °C (64 °F) the values of patient samples are about 10 % lower than at 24 °C (75 °F).
Step Action

Number
CARDIAC D-Dimer
Problem:
Note that a comparison should best be done with Tina-quant D-Dimer as the other lab method might not be standardized.
Background: As with all tests containing mouse antibodies, erroneous findings may be obtained from samples taken from
patients who have been treated with monoclonal mouse antibodies or have received them for diagnostic purposes. In rare
cases though, interferences due to extremely high titers of antibodies can occur. CARDIAC D-Dimer contains additives which
minimize these effects.
It is known that human anti-mouse antibodies (HAMA) Type 1 can lead to falsely elevated results. However, these antibodies
occur very rarely (<0.5 % of blood donors). Blood from patients treated with mouse IgG antibodies (HAMA Type 2) causes no
interference.
D-Dimer is not a homogeneous and clearly defined analyte. The antibodies of the D-Dimer tests react
differently with the spectrum of the fibrin fission products. The different binding characteristics of the
antibodies result in sample-specific differences compared to D-Dimer methods other than Tina-quant D-
Dimer.
values.
Step Action

Number
CARDIAC D-Dimer
Problem:
Possible cause:
Background:
D-Dimer can also be elevated for reasons other than acute thromboembolic diseases. The parameter is
therefore not suitable as an inclusion test, but only as an exclusion test.
Step Action
1 Is the value unspecific elevated?

Number
CARDIAC D-Dimer
Problem:
Possible cause:
Background:
Note: In thrombosis more than one week old, D-Dimer is no longer elevated.
Step Action

Number
CARDIAC D-Dimer
Problem:
Possible cause:
Background:
followed.
to use, in conformity with the instructions for use. CARDIAC D-Dimer Quality Controls must not be used after the printed
2 °C - 25 °C (64 °F - 77 °F) 24 hours

At a temperature of between 4 °C (39 °F) and 15 °C (59 °F), recovery is 10 - 15 % lower.
At 18 °C (64 °F) the values obtained with liquid Quality Controls are about 30 % lower than at 24 °C (75 °F).
When measuring a Level 1 liquid Quality Control without changing the pipette / tip, values may be
elevated when subsequently measuring a Level 2 liquid Quality Control, due to cross-contamination.
Step Action
If the complaint persists request test strips (package) and both liquid Quality Control lots (packages) for inspection

Number
9.4 CARDIAC pro BNP
Problem:
Possible cause:
• Application failure,
• Interferences from triglyceride value <500 mg/dL,
• disturbance of the sample flow
• other interferences
• dilution of sample
Note that a comparison should best be done with Elecsys pro BNP or another NT-pro BNP test as the other lab method
might not be standardized.
Background:
Although BNP and NT-pro BNP are equimolarly released into the blood, due to different half-life in vivo and different stability
in vitro the values are different. Furthermore therapy with recombinant BNP (nesiritide) influences the BNP concentration
but not the NT-pro BNP concentration in plasma
BNP values are not comparable with NT-pro BNP values
Plasma biotin concentrations of > 10μg/L reduce the values with CARDIAC pro BNP
At 18 °C (64 °F) the values of patient samples are about 10% lower than at 24 °C (75 °F).
Sample must not be diluted
Step Action
1 Has the triglyceride value been determined and is the value <500 mg/dL?
2 Has the patient treated with very high doses of biotin?
3 Was the measurement performed at a room temperature of 18 °C (64 °F)?

Number
CARDIAC proBNP
Problem:
Note that a comparison should best be done with Elecsys pro BNP or another NT-pro BNP test as the other lab method
might not be standardized.
Background: As with all tests containing mouse antibodies, erroneous findings may be obtained from samples taken from
patients who have been treated with monoclonal mouse antibodies or have received them for diagnostic purposes. CARDIAC
pro BNP contains additives which are to prevent these effects. In rare cases though, interferences due to extremely high titers
of antibodies can occur.
values.
BNP values are not comparable with NT-pro BNP values.
Step Action

Number
CARDIAC proBNP
Problem:
Possible cause:
Background: Sex, age, renal function, obesity and treatment influence the NT-pro BNP value in patients with congestive
heart failure.
Regard the different normal range values in the package insert.
With a glomerular filtration rate (GFR) < 60ml/min the cut- off values have to be elevated.
Step Action
1 Regard the different normal range values in the package insert between male and female
2 Regard the different normal range values in the package insert between young/old?

Number
CARDIAC proBNP
Problem:
Possible cause:
Background: Sex, age, renal function, obesity and treatment influence the NT-pro BNP value in patients with congestive heart
failure.
Regard the different normal range values in the package insert.

With a body mass index (BMI) > 35 the cut-off values have to be decreased.
Step Action
1 Regard the different normal range values in the package insert between male and female
2 Regard the different normal range values in the package insert between young/old?
3 Is the patient obese?

Number
CARDIAC proBNP
Problem:
Liquid Quality Control Test outside the Control
Range
Possible cause:
Background:
followed.
to use, in conformity with the instructions for use. CARDIAC proBNP Quality Controls must not be used after the printed
2 °C - 25 °C (64 °F - 77 °F) 24 hours

Recovery is too low when the expiry date is exceeded.
When measuring a positive liquid Quality Control without changing the pipette / tip, values may be
elevated when subsequently measuring a negative liquid Quality Control, due to cross-contamination.
Step Action
5 Has the liquid Quality Control test been performed at a temperature of 18 °C (64 °F)?

Number
9.5 CARDIAC CK-MB
Problem:
Note that a comparison should best be done with Elecsys CK-MB as the other CK-MB method might not be standardized.
Background: CK-MB is detectable in the blood approximately 3–6 hours after the first symptoms appear and,
depending on the course of the disease, can remain detectable for approximately 2 to 3 days. CK-MB can also appear
in connection with non-cardiac diseases such as rhabdomyolysis and stroke. In order to differentiate these diseases,
it can be helpful to determine total CK, troponin T and/or myoglobin during laboratory diagnostics. The test sensitivity
of CK-MB determination is dependent on the time of sample withdrawal. It is therefore advisable to perform follow-up
determinations.
Step Action

Number
CARDIAC CK-MB
Problem:
Note that a comparison should best be done with Elecsys CK-MB as the other CK-MB method might not be standardized.
Background: Normally, CK-MB first starts to be released into the blood 3 to 6 hours after myocardial damage has
occurred, though it sometimes starts later. CARDIAC CK-MB thus has a diagnostic window that extends from 2 hours to 3
days.
have been treated with monoclonal mouse antibodies or have received them for diagnostic purposes. CARDIAC CK-MB
contains additives which are to prevent these effects. In rare cases though, interferences due to extremely high titers of
antibodies can occur.
All Cardiac tests are protected against interference from common heterophilic antibodies (blocking agent
MAK33). Patients who have been in contact with animals or have been treated with certain medications
containing monoclonal antibodies can develop new types of heterophilic antibodies against interference
from which the Cardiac tests are not protected. This can lead to falsely elevated or positive values.
Step Action
Number
CARDIAC CK-MB
Problem:
Possible cause:
days. CK-MB may be elevated from conditions other than acute myocardial infarction as other cardiovascular diseases
(unstable angina pectoris, congestive heart failure, arrhythmia and tachycardia, pulmonary embolism), surgical
procedures (open heart surgery, coronary artery bypass graft, valve replacement, coronary angioplasty with
complications, directional atherectomy) or from skeletal muscle origin (normal children, acute skeletal muscle injury,
chronic skeletal muscle injury, myositis, cocaine use)
Step Action
2 Has certain cardiovascular diseases been diagnosed?
3 Has surgical procedures been performed with the patient?

Number
CARDIAC CK-MB
Problem:
Possible cause:
days.
Step Action

Number
CARDIAC CK-MB
Problem:
Possible cause:
Background:
followed.
to use, in conformity with the instructions for use. CARDIAC CK-MB Quality Controls must not be used after the printed
2 °C - 25 °C (64 °F - 77 °F) 24 hours

Recovery is too low when the expiry date is exceeded
When measuring a positive liquid Quality Control without changing the p ip et t e tip, values may be
elevated when subsequently measuring a negative liquid Quality Control, due to cross-contamination.
The plunger may be drawn up only once. Drawing up and expelling the sample several times is not
allowed.
Step Action
inspection

Number
9.6 Roche CARDIAC POC Troponin T
Problem:
Background:
Normally, Troponin T first starts to be released into the blood 2 to 8 hours after myocardial damage has occurred, though it
sometimes starts later. CARDIAC POC Troponin T thus has a diagnostic window that extends from 2 hours to 14 days
Step Action

Number
Problem:
Background: Normally, Troponin T first starts to be released into the blood 2 to 8 hours after myocardial damage has
occurred, though it sometimes starts later. CARDIAC POC Troponin T thus has a diagnostic window that extends from 2
hours to 14 days. Skeletal muscle Troponin T of up to 500 ng/ml leads to a maximum increase of +10 %, at 1000 ng/ml the
increase may reach 30 %. Such very high skeletal muscle Troponin T concentrations only occur in very severe muscle
diseases (e.g. rhabdomyolysis, polymyositis) and/ or muscle injuries, which cannot be overlooked clinically.
have been treated with monoclonal mouse antibodies or have received them for diagnostic purposes. CARDIAC POC
Troponin T contains additives which are to prevent these effects. In some cases though, interferences due to extremely high
titers of antibodies can occur
All Cardiac tests are protected against interference from common heterophilic antibodies (interference filter
MAK33). Patients who have been in contact with animals or have been treated with certain medications containing
monoclonal antibodies can develop new types of heterophilic antibodies against interference from which the
Cardiac tests are not protected. This can lead to falsely elevated or positive values.
Step Action
Number
Problem:
Possible cause:
days. Skeletal muscle Troponin T of up to 500 ng/ml leads to a maximum increase of +10 %, at 1000 ng/ml the increase may
reach 30 %. In very severe muscle diseases (e.g. rhabdomyolysis, polymyositis) and/or injuries the 0.01 % cross- reactivity
can lead to falsely positive values.
Step Action
2 Has myocardial damage been detected?
3 Has renal failure been detected without acute coronary syndrome being diagnosed?

Number
Problem:
Possible cause:
days.
Step Action

Number
Problem:
Possible cause:
Background:
followed.
to use, in conformity with the instructions for use. CARDIAC POC Troponin T Quality Controls must not be used after the
printed expiry date. Maximum stability of components in reconstituted control serum at:
18 °C - 25 °C (64 °F - 77 °F) 24 hours

2 °C - 8 °C (36 °F - 46 °F) 3 days
Step Action

Number
9.7 IQC
9.7.1 Value outside of the confident interval
Problem:
Value outside of the confidence interval
Possible cause:
• Strips stored too long outside of the vial,
• Desiccant stopper of the vial remains open for too long.
• Measurement carried out while strips where not allowed to reach room temperature prior to use
• Wrong storage (Storage and Stability: 4 years at +2 till +30 °C; up to 6 months once the package has been
opened)
• Contamination of the optical system
Background:
The CARDIAC IQC is a set of control strips for verifying instrument performance. It provides users with an easy tool for daily
quality control and helps to keep expenditure at the Point of Care as low as possible.
This quality control set checks only the performance of the Roche cobas h 232 optical system
Allowed Confidence Intervals:

CARDIAC IQC low: from 83,6 to 89,6 % REM +/- 2,5 % REM
CARDIAC IQC high: from 63,1 to 73,1 % REM +/- 3,3 % REM
Refer also the information in the package insert / target value sheet
Step Action
1 If a value is outside the given range, proceed as follows:
Repeat the test with the other Roche CARDIAC IQC test from the same vial.
If the result of this Roche CARDIAC IQC test is within range, the originally used Roche CARDIAC IQC test
which failed must be considered as being defective and must be discarded.
2 If both Roche CARDIAC IQC tests (high and low) are out of range, repeat the check with new, unused container
of Roche CARDIAC IQC tests.
If the problem persists, the instrument and the used IQC strips should be requested for inspection.

Number
9.7.2 IQC level II fails
If IQC level II fails constantly on a meter it can be an indication for a contaminated optical system. The optical system,
mostly the optical mirror, can be contaminated from residues from wrong or inadequate cleaning of the meters inside via
the strip guide area or from strip abrasion.
Please be informed that cleaning of the meter is only allowed as described in the Operator Manual. No material must be
inserted into the meter’s strip guide area than the strip for a measurement.
Step Action
1 If a value for IQC Level II is outside the given range, proceed as follows:
Repeat the test IQC Level II with the other Roche CARDIAC IQC test from another vial.
If the result of this Roche CARDIAC IQC Level II test is than within range, the originally used Roche CARDIAC
IQC test which failed must be considered as being defective and must be discarded.
2 If both Roche CARDIAC IQC Level II tests (high) are out of range, repeat the check with new, unused container
of Roche CARDIAC IQC tests.
If the problem persists, the instrument should be requested for inspection.

Number
(instrument)
10. Wireless LAN
10.1 Wireless LAN
Preliminary note
Appendix B has been developed to explain the wireless communication principles of the cobas h 232 system and to help
your facility’s information technology/management team(s) in effectively deploying the cobas h 232 system on your
wireless network.
Whether your meter is equipped with WLAN functionality or not depends on the system configuration that you purchased.
For information on WLAN registration see the addendum “WLAN registration information, Addendum to the Operator’s
Manual for cobas h 232 POC system” which can be downloaded from the “Point of Care testing” area at www.cobas.com.
Background
The cobas h 232 meter can only be configured through a data management system to communicate wirelessly. The data
management systems is also used to set-up and configure the meter to connect to one hospital specific Wireless Local
Area Network (WLAN). WLANs use electromagnetic waves in the 2.4 and/or 5.0 GHz frequency range to wirelessly
transmit data. The cobas h 232 system adheres to IEEE Standard 802.11g (2.4 GHz range). The system is backwards
compatible to 802.11b. During wireless communication to an Access Point (AP), the cobas h 232 meter recognizes the
existent AP WLAN protocol configuration (802.11b or 802.11g) and automatically transmits data using the appropriate
communication protocol.
The loss of signal or access to bandwidth of one particular client may vary depending on one or more of the following
situations: the type and number of other clients, the performance of the Access Point, the presence of electromagnetic
disturbances, and other potential interfering factors, e.g., concrete walls.
The cobas h 232 meter uses a burst-like communication protocol that will only consume bandwidth if there is actually data
to be transferred. Compared to other applications, such as Voice over Internet Protocol (VoIP) or multi-media applications,
the meter’s bandwidth consumption is minimal. If the WLAN that the cobas h 232 meter seeks to connect to is degraded,
the meter design minimizes the impact on functionality.
Technical implementation
Prior to connecting any wireless device to a wireless network, it is recommended that a WLAN site survey be performed.
The goal of a WLAN site survey is to ensure that Access Points will provide enough coverage and performance to support
any new radio frequency (RF) application or device. The survey will also detail RF signals, including all existing WLANs
along with any competing RF signals and interferences (building structure related and other wireless equipment / devices).
As part of an RF implementation of the cobas h 232 system, it is recommended that at minimum one base unit be hard
wired per floor. A networked base unit provides redundancy if a wireless network malfunctions or loses service. If the cobas
h 232 meter with RF is used in an area with low signal or interferences, it is recommended to install a connected base unit
for redundancy. The redundancy of the connected base unit allows immediate transmission of patient results when the
meter is docked.
The current RF system consists of an antenna and a WLAN system-on-chip (SoC) along with other components. The
WLAN system-on-chip is the core of the WLAN system. The RF system used in the cobas h 232 meter specifically adheres
to the following specifications:
• Its WLAN system-on-chip supports IEEE 802.11b and 802.11g. It works seamlessly together with other Wi-Fi
certified transceivers. It also implements the Wi-Fi Protected Access (WPA™ - Enterprise and WPA™ - Personal),
Wi-Fi Protected Access 2 (WPA2™ - Enterprise and WPA2™ - Personal), and Wired Equivalent Privacy (WEP)
security mechanisms with Temporal Key Integrity Protocol (TKIP) and Advanced Encryption Standard (AES).
In addition, the system supports the extensible authentication protocol (EAP) with EAP-TLS, EAP-
TTLS/MSCHAPv2 and PEAPv0/EAP-MSCHAPv2. The cobas h 232 meter interoperability Wi-Fi certificate can be
accessed at http://certifications.wi-fi.org/search_products.php. Further information including a glossary of terms,
frequently asked questions, and other topics related to Wi-Fi technology can be found on the Wi-Fi Alliance site
(http://www.wi-fi.org/).
• The used channels in the 2.4 GHz-band are channels 1-11. (Channels 12-14 are not used by the cobas h 232
meter.)
• RF output power is approximately 15 dBm at a data rate of 54 MBPS.
RF specific functionalities and effective performance claims

The cobas h 232 system offers the option of wireless network connectivity (WLAN/Wi-Fi). If you purchase a system with
this option, the WLAN function is enabled during production. This module can only be configured by a data management
system (DMS), which activates the meter’s wireless communication and data transfer capabilities. Wireless connectivity
can help to ensure that updates to information in the DMS are sent immediately to all networked meters. Communication
takes place when the meter is idle, but will be interrupted during the performance of a test.
Meters with an integrated and activated wireless option use the base unit for recharging and/or as a redundant
communication option to exchange data with the DMS.
The meter also has to be docked if the hospital changes security protocols. When this change occurs, it may lock out all
meters until docked and reconfigured with the new protocol.
As described above, the cobas h 232 meter supports the 802.11g standard. This translates into the following RF specific
performance claims:
• The cobas h 232 meter is capable of transferring to a suitable DMS, via WLAN, a data set of up to 1000 result
records, 100 reagent records, and 500 operator ID records in less than 15 minutes, when operated in a typical
WLAN environment (correct WLAN administration, typical population of other clients present, any of the supported
security models enabled).
• A cobas h 232 meter with wireless connectivity enabled will communicate results after every test or when the meter
is idle; it will automatically attempt to communicate with the DMS every 10 minutes. In line with the industry
communication standard POCT1-A, the DMS must acknowledge the meter’s request for connection and actively
query for the result. Only upon receipt of this DMS query, the meter will send the result. Hence the effective time
for transmitting results depends on infrastructure, DMS workload, etc. Once the DMS sends a query, however, the
meter will respond within a few seconds.
A typical range for direct connection between the cobas h 232 meter and the access point (air, direct view, low
disturbances) is up to 15 to 20 meters (49 to 66 feet). The actual range depends on the positioning of the access point’s
antennas and other topological properties of the space between WLAN device and AP. Additionally, dynamic control of the
transmitting power of the access point may reduce the maximum distance between WLAN device and AP within which
communication can be guaranteed.
The cobas h 232 system is designed such that it coexists with other wirelessly communicating devices. The cobas h 232
system does NOT include any real-time or even time critical wireless functionality. It communicates exclusively single,
digital data fields. It does NOT communicate continuous waveform data.
Note: A degraded Quality of Service (QoS) of the WLAN communication will not impact the functionality of the meter but
may delay the communication of results to the DMS. Users should be aware that real-time communication of test result
readings cannot be guaranteed by the cobas h 232 meter.
10.2 Trouble shooting WLAN
Refer also to the Handheld Platform Connectivity Troubleshooting Guide as available in GRIPS
10.2.1 Updated instructions to install a new RF card

The RF card for the wireless network communication is built in to the cobas h 232 and must not be exchanged in the field.
10.2.2 Wireless communication not established

When a wireless enabled meter is docked in a base unit, the following applies:
The WLAN test feature of the Diagnostics menu may help to determine cause for the communication issue.
Possible failure Possible solution

Meter battery capacity is below the threshold. RF Charge battery for at least 30 mins. One segment of the battery icon
function is disabled. WLAN test will fail at should be filled.
“activate”
Wireless network out of reach. Relocate meter
(RF is activated but fails to associate)
Typo in WLAN settings received from DMS. Have the check with IT department if any entry in the configuration is
(RF is activated but fails in either of the next wrong. Observe case sensitivity of SSID and security credentials.
step. The failed step indicates which setting may
be erroneous) Refer to Handheld Platform Connectivity Troubleshooting Guide in
GRIPS for more details.
No or wrong configuration received. Navigate to the Diagnostics menu, and review if data are the same
(No antenna icon in meter display) as in DMS.
WLAN temporarily disabled via display button Power meter off and on again
(No antenna icon in meter display)
Meter outside the temperature range for RF Power meter off and on again
operation
(No antenna icon in meter display)
Defective RF card/controller hardware suspected Reset meter
Power meter off and on again
If the failure persists, the meter must be recalled for an investigation

Number
(instrument)
10.2.3 Results not transmitted via WLAN
Results will be transmitted via WLAN to the DMS immediately only after correct conclusion of the measurement. Formal
conclusion requires the following actions from the operator:
• confirm result with checkmark, add comments if required.
If the result is not acknowledged, the meter will power off after 10 mins and transmit the result in the following
communication cycle.
Possible failure Possible solution
Operator has not formally concluded the Advice the caller to always remove the test strip after measurement
measurement as described above. and to confirm the result.

Number
11. Appendix
11.1 Package inserts Roche CARDIAC strips
The package insert is a subject of chances.
To ensure that always the latest and valid version is used, please obtain the package inserts or instructions for use directly
from GRIPS.
11.2 Lot Specific Values
Per specification there are no target value sheets for the Roche Cardiac test strips for the cobas h 232 instruments
available. Instead of a paper version, the information for the upper and lower limit of the range as well the target value are
stored on the lot specific code chip and will provided to the instrument upon initial usage of the lot specific code chip.
It was proofed lately that with the current workflows during production and labelling it is not possible to create or to provide
target value sheets for the Roche Cardiac test strips for the cobas h 232 instruments neither in paper format nor in digital
format to be published in example in GRIPS.
The customer will definitively not miss any information; all information is stored on the lot specific code chip provided with
the controls. Moreover, the range and the target for a control lot / strip lot combination can be displayed on the cobas h 232
instruments after an initial measurement with the control.
Refer also to the cobas h 232 instrument operator manual.
Inquires send per global complaint handling system with requests for the target value or target value sheets are not
necessary as this information is available on each lot specific code chip of the controls already.
As described above, the information can be easily looked up from the instrument itself.
Same applies for the Roche Cardiac IQC strips.
11.3 General Question for pre-analytics and sample preparation
A list of questions which might help to find problems which might occur during pre-analytics and sample preparation:
• Was the procedure according to the trouble shooting guide carried out?
• Where different lots used?
• If so, please provide all strip lot numbers.
• When was a cleaning and QC on the instrument carried out?
• Where other assays measured with the instrument and where there also problems?
• Please provide a digital picture of the used strips.
• If possible, collect some of the used strips to see the flow of the sample along the strip.
• Can sample application failure be excluded?
• Did the failure appear always with sample from the same patient?
• Did the failure appear always with the same user?
• Could somebody witness the correctness of sample drawing and sample application?
• Was the sample measured on a different lab system?
• If so, which one?
• Please provide followings information about the system and the measured values
• Which pipettes have been used to apply the sample to the strips?
• Are Roche Cardiac Pipettes are used?
• Was the HB value of the sample obtained? In the package inserts (of all Cardiac parameter) the max. HB value
can be found (max HB value is 14 - 17,5 g/dL)
More Information about the heparinization, type of tubes used, etc.

• Which Heparin type was used?
• Does the problem appear on samples from different patients?
• Does the problem appear when using different strip lots?
• Is the sample soaked up completely?

• Did the failure appear when inserting the strip?
• Could the measurement be started?
• Was the measurement carried about correctly till its end?
• If the measurement was aborted from the instrument, when (approx. time after start of the measurement)?
• Known interferences due to medical drugs?

• Drug list and medical history of the patient?
Instruments with serial number < KQ0120000 and < KS0210000 only:
• Does the instruments error log give indications for “purple plaque”? Refer also to Product Bulletin 2014/003
• Does the failure appear during IQC (Level II)? >> Cleaning of the instrument?
• Does the failure appear during QC as well?
11.4 General Remarks Sample Preparations:
Heparinized venous whole blood is used as sample material. For each test with the cobas h 232 meter, you need a
quantity of exactly 150 µL.
Tubes:
There are color codes for tubes but the color of the tube's plastic cap is not always standardized across manufacturers. In
all case refer to the package inserts for the information regarding the usage of tubes. All tubes listed there have been
evaluated and might be used without problems.
Note:
Using the wrong tube will make the blood sample unusable.
Storage:
Sample must not be centrifuged
Sample Application:
Mechanical action pipettes require a relatively high level of care to ensure they are always functioning correctly. Corrosion or
leaking within the pipette can occur and these failures are not easily detectable by the user, so incorrect volumes can be
applied.
collection vial.
Make sure the sample contains no air bubbles. Apply the entire sample to the application area of the test strip.
Always place the meter on a level, vibration-free surface while applying the sample until the necessary
sample has been absorbed completely by the test strip.
The pipette should be held in a vertical position to avoid spilling of the blood sample. Also, do not touch the test strip with the
pipette and assure that the needle does not penetrate the strip.
After the measurement

Remove the test strip from the instrument.
• Dispose of the test strip according to local guidelines

• Dispose used pipettes and test strips in a sturdy sharps container with a lid.
• Discard used disposable items and strip in compliance with the disposal policy of your hospital or medical practice.
For information about correct disposal please contact your local council or authority.
Furthermore, follow all hygiene and safety regulations in force locally.
Back
11.5 Cleaning of the Instrument
11.5.1 Cleaning of the instrument ONLY according to Operator manual.

• Make sure the meter is powered off. Unplug the power adapter.
• Do not spray anything onto the meter housing.
• Do not spray into the test strip guide.
• Do not immerse the meter in liquid.
• Use only ordinary lint-free tissues.
• Do not use cloths that are saturated. Squeeze off excess solution or blot on a dry paper towel to remove
any excess solution before wiping the surface of the meter.
11.5.2 Recommended cleaning/disinfecting solutions

Use only the following solutions for cleaning/disinfecting the meter (housing and the test strip guide cover).
Before using a cleaning/disinfecting solution on the meter refer to the product labeling for required contact time for
cleaning/disinfecting and to ensure that the active ingredients are acceptable for use. Prepare all solutions per the
manufacturer’s product labeling. Acceptable active ingredients are listed below.
Recommended cleaning agents
• mild soapy water
• 70 % (or less) solution of isopropyl alcohol in water
• 0.625 % (or less) solution of sodium hypochlorite in water (bleach)
Recommended disinfecting agents

• 0.625 % (or less) solution of sodium hypochlorite in water (bleach)
• 70 % (or less) solution of isopropyl alcohol in water
11.5.3 Cleaning/disinfecting the exterior (meter housing)

Clean the meter whenever it becomes dirty. You can also use the device-specific “Cleaning Lockout” function (see operator
manual) to ensure regular checks are performed.
Use only the solutions recommended above.
Basic sequence of steps for cleaning
• First remove any blood and other dirt using water or mild soapy water.
• Then disinfect the meter's housing.
NOTICE Do not use any other disinfectants/cleaning solutions on the meter (housing or the test strip guide cover). Use of
other disinfectants/cleaning solutions could result in damage to the meter.
Refer to the safety information provided on the packaging of the products when using the chemical cleaning agents
mentioned above. Some of the agents must not be used together as this may result in undesirable reactions. Follow the
manufacturer's instructions
11.5.4 Cleaning after contamination due to mispipetting
Observe the following precautions to prevent instrument damage
• Do not move the meter to prevent liquids from creeping and penetrating the meter.
• Dab away all visible blood (also on the test strip, but not in the application area).
• Do not use the meter before the liquid/moisture has been completely removed. While it is drying, the meter must
not be moved as this may soil the optical components.
For detailed cleaning instructions (“how to clean…”) for the individual components of the meter, see the pages from the
operator manual. The instructions below describe only the sequence of steps to be taken in case of mispipetting.
• Remove the test strip guide cover.
• Remove and dispose of the test strip.
• Clean the soiled parts of the meter with a moistened cotton swab/bud or tissue.
• Disinfect the meter.
11.5.5 Cleaning the test strip guide cover

Step 1 If required, remove the meter from the Handheld
Base Unit and place it horizon tally on a table.
Step 2 Remove the test strip guide cover by pulling it

forward horizontally (in the direction of the arrow).
Move the cover safely away from the meter and wipe it clean
using the solutions recommended
In case of significant soiling or contamination, you can rinse

the test strip guide cover with warm water, dry it with a fresh
tissue, and then disinfect it using the solutions.
Always ensure that the test strip guide cover is completely

dry before re-attaching it to the meter.
Step 3 Clean the outside of the meter with a lightly

moistened tissue. Then dry the meter with a fresh tissue.
11.5.6 Cleaning the visible area of the test strip guide
Step 1 Clean the easily accessible and visible pipetting

field area of the test strip guide with a moistened cotton
swab/bud or tissue. Then dry the test strip guide with a
fresh tissue.
Adhere to the following:
Clean only the visible area of the test strip guide.

Do not insert any objects into the concealed areas of the
test strip guide as this will damage the optical components
of the meter.
Do not use objects to try to scratch off any dried
contaminants in the test strip guide, nor use any kind of
liquids or spray on or in the concealed areas
Step 2 Clean the membrane (small circle in picture below)

in the visible area at the end of the test strip guide with a
moistened cotton swab/bud or tissue.
Step 3 Allow the inside of the test strip guide to dry for
about 10 minutes.
Step 4 After this time, re-attach the test strip guide cover
to the housing. Make sure that the cover is properly
attached. You will feel it snap into place.
11.6 QC Recommendation
Refer also to:
• Product Bulletin No. 2008/004, RPD Decentralized, Mannheim
• Support Notification SN-RPD-2015-159
Manufacturer recommended use:
Please note also that QC recommendations by national associations or local hospital guidelines take precedence over
manufacturer recommendations.
For more details on the procedure, refer to the operator`s manual and instruction for use.
11.7 Picture Gallery
Note:
This gallery is a collection of images to visualize failure and to point out possible failure sources. Therefore, the images in
the gallery provide hints only and can possibly be of a help pointing into the direction of a possible cause for a failure.
A visual inspection of the strip can provide information, too. The strip cover can be opened and the strip can be
investigate visually to get a clearer understanding about the sample flow

Observe always the general precautions and guidelines relating to blood sampling when
working with patient’s samples.
visible failure Possible root cause
• Overdosing , control line not visible anymore

• Wrong heparinization of the sample,
• Wrong tubes (refer to package insert),
• Handling (preparation, pipetting, etc.)
Measurement will be aborted,

Instrument will release an error message
• Under dosing,
• Sample did not reach detection zone

• Under dosing,
• Sample hemolytic

• Under dosing

• Under dosing
Measurement will most likely not start, it will be

aborted,
• Sample hemolytic
Measurement will most likely not start, it will be

aborted,
Sample too reddish.
Control line not clearly visible on background. Meter

will abort the measurement with E-402
• Strip failure,
• Triangle shape of sample flow
• Sample flow not linear along the strip
Measurement will be aborted, if started

• Signal line interrupted

• Strip failure
Measurement will be aborted, instrument will release

an error message
• Spot on sample application area,

• Contamination prior to usage?
• Production failure?
Most likely interference of sample
Both lines appear interrupted, triangle shaped spikes

have washed out already bind antibodies
• Barcode scratched
Instrument will release an error message if barcode is

not readable.
• Barcode under strip incorrect printed
Instrument will release an error message as barcode

is not readable.
• Strip cover damaged
• Cartonage particle in strip.

Packing issue.
• Strip port blocked with remaining “paper” from

cleaning
Instrument will most likely release an Error E-205
Residues on optical mirror.
As a result measurements will be aborted.
(View from camera onto the strip)
Root cause: Wrong cleaning of the instrument.

Possibly an Error 402 will be released
Filament in strip insert.

As a result measurements will be aborted.
Root cause: Wrong cleaning or use of contaminated

strip.
Most likely an Error 402 will be released
Residues from cotton pads an blood inside of the strip

guide area.
As a result the strip cannot be inserted completely.
Error 205 will be released.
Root cause: Wrong cleaning of the instrument.
Blood splatters on the UPPER mirror.

As a result, the measurement will be aborted if it can
be started at all.
Root cause: wrong handling. Most likely sample
application while the strip was still not inserted, after
dosing, etc.
Blood splatters on the UPPER mirror.

As a result, the measurement cannot be started at all.
Root cause: wrong handling. Most likely sample
application while the strip was still not inserted, after
dosing, etc.
Contamination of upper mirror due to wrong cleaning.
Result:
Measurement will not start or will be aborted if started;
an error will be displayed instead.
Window of bar code reader broken, most likely after

fall or drop of the meter.
Result:
Measurement will not start or will be aborted if started;
an error will be displayed instead.
Flap at strip insert jammed and remains in upper
position
Will cause E-204 upon insertion of a strip for a new

measurement
Refer also to Quality Notification QN-RPD 2015-020
Cleaning residues on the UPPER mirror.

As a result, the measurement will be aborted if it can
be started at all.
IQC will most likely fail.
Root cause: wrong handling. Most likely wet cleaning
of the meters via strip guide
Corrosion of an electronically board by liquid entered

into the meter
Unauthorized opening of a meter
11.8 Ordering Information
In case of questions, please contact your supplier specialist.
Note: Not all items are available in all countries.
Product Limitations
Please read the information in the package insert supplied with the test strips for detailed product data and limitations.
Item Description REF REF

Roche CARDIAC T 10 tests for quantitative detection of cardiac Troponin T 4877772190
Quantitative
Roche CARDIAC Control Control set for use with Roche CARDIAC T Quantitative 4890515190
Troponin T
Roche CARDIAC POC 10 tests for quantitative detection of cardiac Troponin T 7007302190
Troponin T
POC Troponin T
Troponin T (Germany
only)
Roche CARDIAC M 20 tests for quantitative detection of myoglobin 4877799190
Roche CARDIAC Control Control set for use with Roche CARDIAC M 4890469190
Myoglobin
Roche CARDIAC D-Dimer 10 tests for quantitative detection of D-Dimer 4877802190
Roche CARDIAC Control Control set for use with Roche CARDIAC D-Dimer 4890523190
D-Dimer
Roche CARDIAC proBNP 10 tests for quantitative detection of NT-proBNP 4877845190
Roche CARDIAC 10 tests for quantitative detection of NT-proBNP 5533643190

proBNP+
Roche CARDIAC Control Control set for use with Roche CARDIAC proBNP and 4890493190
proBNP Roche CARDIAC proBNP+
Roche CARDIAC CK-MB 10 tests for quantitative detection of CK-MB 4877900190
Roche CARDIAC Control Control set for use with Roche CARDIAC CK-MB 4890426190
CK-MB
Roche CARDIAC IQC Set of two re-usable control strips (high/low) including 4880668190
code chip.
Roche CARDIAC pipettes 20 disposable syringe pipettes (150 μL) for blood 11622889190
application
Universal battery pack Rechargeable battery pack for cobas h 232 meter 06869904001
Test strip guide cover 07751109001
Battery compartment 07751125001

cover
Power adapter 07006098001
Handheld Base Unit 4805658001
cobas h 232 meter Version without scanner/without WLAN 04901126190
cobas h 232 Version with scanner/with wireless LAN 04901142190

scanner/WLAN
cobas h 232 Operator’s Printed manual (English) 07469101001

Manual
cobas h 232 Operator’s Printed manual (German) 07532920001

Manual
cobas h 232 Manual CD Operator’s Manuals and Quick Reference Guides in all 07469314001
avail. languages (PDF)
Printer cobas h 232 (CMP- for most North American, Latin American and 05404495001
10) ROW Asian countries
Printer cobas h 232 (CMP- for most European, Middle East and African countries 05404517001
10) EMEA
Printer cobas h 232 (CMP- for Japan 05404509001

10) JAP
Normal thermal paper roll 5 rolls per package, 50 mm diameter 03666751001
Thermal paper roll (self- 10 rolls per package, 50 mm diameter 05412951001

adhesive)
Note: Not all items are available in all countries.
11.9 Category and Cause Codes
Category and Cause Codes used in the failure section have been chosen based on most common failure and experiences.
They have therefore to be seen as a guideline for only.
Category Code Cause Code
Chassis, Housing Component missing

Component wrong / damaged
Contamination
Damaged
Label missing
Mechanical Failure
No Cause found
Prod. does not meet cust. expectation
Other / Unknown
Electronic systems (instrument) Component wrong / damaged
Contamination
Damaged
Electronic Failure
No Cause found
Operator Error / Technique / Handling
Other / Unknown
Information / Customer Request Operator Error / Technique / Handling
Operator's Manual
Package Insert
Patient Sample
No Cause found
Storage
Other / Unknown
Labeling / Documentation Component missing
Damaged
Label / Box erroneous
Label missing
No Cause found
Operator's Manual
Package Insert
Other / Unknown
Packaging Component missing
Damaged
No Cause found
Label / Box erroneous
Label missing
Other / Unknown
Packaging: Missing Item Coding Missing/Unreadable/Incorrect
Component missing
Label missing
No Cause found
Other / Unknown
Power Supply / Battery Component missing
Contamination
Damaged
No Cause found
Other / Unknown
Preanalytics / Sample Handling Component missing
No Cause found
Patient Sample
Other / Unknown
No Cause found
Non-Roche Product
Patient Sample
Component missing
Other / Unknown
Test strip / disk defective (no questionable results) Component missing
Damaged
Mechanical Failure
Contamination
No Cause found
Non-Roche Product
Storage
Other / Unknown
Use / User Error Contamination
Damaged
Mechanical Failure
No Cause found
Storage
Operator's Manual
Other / Unknown
User Interface (Display / Touch) Damaged
Electronic Failure
Mechanical Failure
No Cause found
Other / Unknown
Others/New Errors Damaged
Electronic Failure
Mechanical Failure
Method Comparison
No Cause found
Non-Roche Product
Software Failure
Other / Unknown
Software failure Coding Missing/Unreadable/Incorrect
No Cause found
Software Failure
Other / Unknown
11.10 Symbols and signs
Roche Diagnostics uses the following symbols and signs in addition to those listed in the ISO 15223-1:2007
standard.
REF Catalogue number
LOT Batch code
IVD In vitro diagnostic medical device
CONTENT Contents of kit
REAGENT Reagent
CALIBRATOR Calibrator
CONTROL Control
DILUENT Diluent
Manufacturer
Contains sufficient for <n> tests
Use by
Temperature limitation (Store at)
This way up
Volume after reconstitution or mixing
Consult instructions for use
For IVD performance evaluation only Caution,
consult accompanying documents Biological risks
(Potentially bio hazardous material) Harmful
Irritant
Corrosive
Corrosive
This product fulfills the requirements of the European Directive 98/79

EC REP
EC for in vitro diagnostic medical devices

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cobas h 232 POC System

Trouble Shooting Guide

FOR TELEPHONE SERVICE AND TECHNICAL SERVICE

Date Version Modification Page

Please read carefully all text proceeded by the following symbols:

1.3 Product Inquiries and Complaints

Dr. Antonia Pop-Karadavut

Telephone: +49 621 759 5429

E-Mail address: antonia.pop@roche.com

2.2 Explanation of Version ID

cobas h 232 / Version 4.0 / Dec 2018 / Page x

The system code for cobas h 232 is: KQ

The system code for cobas h 232 with scanner is: KS

2.3 Detection of theinstruments firmware version

2.4 Reset of the meter

The cobas h 232 is not reparable in the field

3.2 Intra-Company Warranty Period for Instruments

Since the year 2003 intra-company warranty is terminated.

Find up-to-date information in the ROCHE Intranet

3.3 Local Warranty Period

Local warranty is defined by the local sales organization.

3.4 Complaint Management

3.4.1 LocalAssessment of Customer Complaints

Key elements for local assessment of customer complaints are:

A. Customer on the Phone:

B. Complaint product returned from customer to CPS:

B1. Strips are returned for inspection:

B2. An instrument is returned for inspection:

C. Customer complaint cannot be handled or solved locally:

3.4.2 Reporting of Quality Issues "Locally Solved" in the Country organization

Continued on next page

3.5 User Error Codes

Operating conditions and technical data

Measuring range Depends on test parameters

Interface Infrared interface, LED/IRED Class 1

Battery operation Universal battery pack (HBM4.x)

Number of tests with fully approx. 10 tests

Storage and transport conditions

C Opening for sample application

D Test strip guide cover

H Wireless LAN Label

J Infrared (IR) window

K Connection socket for power adapter

L Code chip slot

N Universal Battery Pack O Power adapter

P Test area R Barcode

Continued on next page

T Charging contacts X Data ports (Ethernet/RJ45 and USB)

Quick Access (Description)

Errors without specific failure number

Error when powering on

Sound not working

Errors in Documentation / Labelling failure

Visible Meter Defects

Access to Instruments Error log / Password of the day

E 101 E 201 E 301 E 401 E 501 E 601 E 701 E 801 I 001

E 102 E 202 E 302 E 402 E 502 E 602 E 702 I 002

E 103 E 203 E 303 E 403 E 503 E 603 E 703 I 003

E 104 E 204 E 304 E 404 E 504 E 604 E 704

E 105 E 205 E 305 E 405 E 605 E 705 E 805

E 106 E 206 E 306 E 606 E 706 E 806 I 006

E 107 E 207 E 307 E 607 E 707 E 807 I 007

E 108 E 208 E 308 E 608 E 708 I 008