Au 680

August 23, 2010
Attachment A
Detecting and Resolving Cuvette Overflow
A) Definition of Cuvette Overflow
After each measurement, the reaction fluid in a cuvette is aspirated, and the cuvette is washed
and dried. In the case of a system malfunction, fluid may spill over onto the outside of the
cuvette and affect the next measurement in that cuvette or a neighboring cuvette, potentially
leading to an incorrect result (both falsely high and falsely low).
Our internal investigation has indicated that even a minor cuvette overflow can affect assay
results and reaction monitors for at least the following 3 hours.
B) Detecting a Cuvette Overflow

A list of assays (refer to Table 1) susceptible to being impacted by a cuvette overflow are
shown below. These assays are called Overflow Indicator Assays. Ensure that at least one
Overflow Indicator Assay is performed at the beginning of each run, on each cuvette ring, and
at a minimum of every 3 hours of operation. Either a patient sample or a QC sample may be
used for an Overflow Indicator Assay sample.
Indicator OSR # Indicator OSR # Indicator OSR #

Assay Assay Assay
Bilirubin-D 6x11 CRP 6x99 Total Protein 6x32
Bilirubin-T 6x12 Glucose 6x21 Triglyceride 6x118
Ceruloplasmin 6x64 Iron 6x86 Uric Acid 6x98
Cholesterol 6x16 Magnesium 6x89
Creatinine 6x78 Phosphorus 6x22
Table 1: List of Overflow Indicator Assays
Before releasing test results, verify that the reaction monitor of the Overflow Indicator Assay
is consistent with a normal reaction monitor for your specific AU system as shown in Section E
(Reaction Monitor Library) of this document. For information on how to display the reaction
monitor, refer to your User Guide under the section, “Displaying Reaction Monitor”.
• If the reaction monitors of your Overflow Indicator Assays match the normal profiles
shown, the results of the AU analyzer are acceptable and may be released.
• If the reaction monitors of your Overflow Indicator Assays do not match the normal
profiles shown, identify whether a cuvette overflow occurred as directed under Section C
of this letter. Examples of abnormal reaction monitors for specific AU systems are shown
in Section E. However, these abnormal monitors are only examples – abnormal reaction
monitors may have many variations. Again, if your reaction monitors for the Overflow
Indicator Assays do not match the normal profiles, proceed to Section C.
If you are not sure whether the reaction monitor of your Overflow Indicator Assay is normal,
call your local service organization.
FSN-14563
Beckman Coulter United Kingdom Limited Telephone 01494 441181
Oakley Court Fax 01494 429291
Kingsmead Business Park e-mail infouk@beckman.com
London Road High Wycombe Website www.beckmancoulter.co.uk
Bucks HP11 1JU Registered in England no 640961 Registered Office as shown
Page 1
Attachment A
Detecting and Resolving Cuvette Overflow
C) Confirming a Cuvette Overflow
If you identify an abnormal reaction monitor for an Overflow Indicator Assay, an instrument
malfunction may have occurred. To confirm whether a cuvette overflow occurred, perform the
following checks:
• Verify the reaction monitors of other samples run prior to your first abnormal sample. If
these reaction monitors are also abnormal, assume that a cuvette overflow has occurred.
• Examine the tops of the reaction cuvettes, following the instruction in your User Guide.
The tops of the cuvettes should appear frosty or white. If they are dark or black, remove
the cuvettes from the wheel to determine if an overflow has occurred.
If you have confirmed a cuvette overflow occurred, proceed to Section D.
If your prior reaction monitors for Overflow Indicator Assays are normal, and the tops of the
reaction cuvettes are frosty or white, then the reason for the abnormal reaction monitor is still
unknown and standard trouble-shooting actions are required, as described in the system User
Guide.
D) Recovering from a Cuvette Overflow and Rerunning Patient Samples

Before starting any recovery actions to bring the instrument back into routine operation, it is
very important to identify the cause of the cuvette overflow. If the cause is not identified, the
risk of recurrence is very high.
The following instrument malfunctions have been identified as the primary causes of cuvette
overflows:
• Blocked or partially blocked cuvette wash station nozzles
• Valve failure
• Misalignment of wash station components
• Disconnected wash station tubing
• Deterioration of wash station o-rings
To identify a cause, check the wash station for nozzle blockages, valve failures, misalignment,
disconnected tubing or worn o-rings.
As always, daily maintenance is essential to identify hardware deterioration before it affects
system performance. Many cuvette overflow incidents are the result of incorrect handling of
the cuvette Wash Station during user maintenance. When parts are removed or replaced as
part of user maintenance, you must ensure they are handled and repositioned correctly. Refer
to the Maintenance section of your User Guide for correct instructions and ensure that users
who perform maintenance are sufficiently trained to perform those maintenance tasks.
If the reason for cuvette overflow is not identified, contact Beckman Coulter for service.
If you have identified the cause and repaired the instrument, perform the Overflow Recovery
steps describe in your User Guide, including passing the photocal, to achieve standard
operation of the system.
After proper system operation is verified, rerun all samples between
the abnormal Overflow Indicator Assay and the last normal Overflow
Indicator Assay.
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Page 2
Attachment A – Section E
Reaction Monitor Libraries
E) Reaction Monitor Libraries
This section provides examples of normal and abnormal reaction monitors for Overflow
Indicator Assays on specific AU Systems. In assessing the reaction monitors for the
Overflow Indicator Assays, please refer to the appropriate section (E1- E5) for your particular
system, specifically:
Section E1: AU 2700 and AU 5400
Section E2: AU 680
Section E3: AU 640
Section E4: AU 480
Section E5: AU 400
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Page 3
Attachment A- Section E2
AU 680 Reaction Monitor Library
Section E2: AU680 Reaction Monitor Library:
Examples of normal and abnormal reaction monitors for

Overflow Indicator Assays on the AU 680 System.
Table of Contents
AU 680 Creatinine (OSR6x78) Norman 5
AU680 C-Reactive Protein (OSR6x99) Normal 7
AU680 C-Reactive Protein (OSR6x99) Abnormal 8
AU680 Iron (OSR6x86) Normal 9
AU680 Direct Bilirubin Color (OSR6x11) Normal 11
AU680 Direct Bilirubin Color (OSR6x11) Abnormal 12
AU680 Ceruloplasmin (OSR6x64) Abnormal 14
AU680 Magnesium (OSR6x89) Normal 15
AU680 Magnesium (OSR6x89) Abnormal 16
AU680 Total Bilirubin (OSR6x12) Normal 17
AU680 Total Bilirubin (OSR6x12) Abnormal 18
AU680 Uric Acid (OSR6x98) Normal 19
AU680 Uric Acid (OSR6x98) Abnormal 20
AU680 Glucose (OSR6x21) Normal 21
AU680 Glucose (OSR6x21) Abnormal 22
AU680 Phosphorus (OSR6x22) Normal 23
AU680 Phosphorus (OSR6x22) Abnormal 24
AU680 Triglyceride (OSR6x118) Normal 25
AU680 Triglyceride (OSR6x118) Abnormal 26
AU680 Cholesterol (OSR6x16) Normal 27
AU680 Cholesterol (OSR6x16) Abnormal 28
AU680 Total Protein (OSR6x32) Normal 29
AU680 Total Protein (OSR6x32) Abnormal 30
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Section E2 - Page 4
AU 680 Creatinine (OSR6x78) Normal
AU680 Creatinine (OSR6x78) Abnormal
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Section E2 - Page 5
AU680 Creatinine (OSR6x78) Abnormal
FSN-14563
Section E2 - Page 6
AU680 C-Reactive Protein (OSR6x99) Normal
AU680 C-Reactive Protein (OSR6x99) Abnormal
FSN-14563
Section E2 - Page 7
AU680 C-Reactive Protein (OSR6x99) Abnormal
FSN-14563
Section E2 - Page 8
AU680 Iron (OSR6x86) Normal
AU680 Iron (OSR6x86) Abnormal
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Section E2 - Page 9
AU680 Iron (OSR6x86) Abnormal
FSN-14563
Section E2 - Page 10
AU680 Direct Bilirubin Color (OSR6x11) Normal
AU680 Direct Bilirubin/ Color (OSR6x11) Abnormal
FSN-14563
AU680 Direct Bilirubin Color (OSR6x11) Abnormal
FSN-14563
AU680 Ceruloplasmin (OSR6x64) Normal
AU680 Ceruloplasmin (OSR6x64) Abnormal
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AU680 Ceruloplasmin (OSR6x64) Abnormal
FSN-14563
AU680 Magnesium (OSR6x89) Normal
AU680 Magnesium (OSR6x89) Abnormal
FSN-14563
AU680 Magnesium (OSR6x89) Abnormal
FSN-14563
AU680 Total Bilirubin (OSR6x12) Normal
AU680 Total Bilirubin (OSR6x12) Abnormal
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AU680 Total Bilirubin (OSR6x12) Abnormal
FSN-14563
AU680 Uric Acid (OSR6x98) Normal
AU680 Uric Acid (OSR6x98) Abnormal
FSN-14563
AU680 Uric Acid (OSR6x98) Abnormal
FSN-14563
AU680 Glucose (OSR6x21) Normal
AU680 Glucose (OSR6x21) Abnormal
FSN-14563
AU680 Glucose (OSR6x21) Abnormal
FSN-14563
AU680 Phosphorus (OSR6x22) Normal
AU680 Phosphorus (OSR6x22) Abnormal
FSN-14563
AU680 Phosphorus (OSR6x22) Abnormal
FSN-14563
AU680 Triglyceride (OSR6x118) Normal
AU680 Triglyceride (OSR6x118) Abnormal
FSN-14563
AU680 Triglyceride (OSR6x118) Abnormal
FSN-14563
AU680 Cholesterol (OSR6x16) Normal
AU680 Cholesterol (OSR6x16) Abnormal
FSN-14563
AU680 Cholesterol (OSR6x16) Abnormal
FSN-14563
AU680 Total Protein (OSR6x32) Normal
AU680 Total Protein (OSR6x32) Abnormal
FSN-14563
AU680 Total Protein (OSR6x32) Abnormal
FSN-14563

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August 23, 2010

B) Detecting a Cuvette Overflow

Indicator OSR # Indicator OSR # Indicator OSR #

D) Recovering from a Cuvette Overflow and Rerunning Patient Samples

Section E1: AU 2700 and AU 5400

Section E2: AU 680

Section E3: AU 640

Section E4: AU 480

Section E5: AU 400

Examples of normal and abnormal reaction monitors for

AU680 Creatinine (OSR6x78) Abnormal

AU680 C-Reactive Protein (OSR6x99) Abnormal

AU680 Iron (OSR6x86) Abnormal

AU680 Direct Bilirubin/ Color (OSR6x11) Abnormal

AU680 Ceruloplasmin (OSR6x64) Normal

AU680 Ceruloplasmin (OSR6x64) Abnormal

AU680 Magnesium (OSR6x89) Abnormal

AU680 Total Bilirubin (OSR6x12) Abnormal

AU680 Uric Acid (OSR6x98) Abnormal

AU680 Glucose (OSR6x21) Abnormal

AU680 Phosphorus (OSR6x22) Abnormal

AU680 Triglyceride (OSR6x118) Abnormal

AU680 Cholesterol (OSR6x16) Abnormal

AU680 Total Protein (OSR6x32) Abnormal

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