PROCEDURE

FSE QCV ALERT MANAGEMENT

For Internal Use Only - EN

CSN 1901-1 PROCEDURE - FSE QCV ALERT MANAGEMENT 1

 Table of Contents

Table of Contents..............................................................................................................................2

1. Aim of this Procedure ...............................................................................................................3

2. Investigation at Customer site..................................................................................................3

2.1. Troubleshooting for TV1 issue .............................................................................................3
2.2. Troubleshooting for R3 issue ...............................................................................................4
2.3. Troubleshooting for R3 and TV1 issues ................................................................................4
2.4. Root cause ...........................................................................................................................4

3. Field Service Engineer Report ..................................................................................................4

4. bioMérieux recommendation ....................................................................................................5

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1. Aim of this Procedure

This procedure describes all the necessary steps to manage a QCV Alert on a VIDAS/ MiniVIDAS
system, at customer site.
It’s intended for use by bioMérieux Field Service Engineers.

The FSE must collect and confirm all important data during the intervention, the aim is:

o To determine the context of the issue,

o To obtain information on the customer system
o To identify the root cause BEFORE repairing the instrument
o To complete the FSE report (see …)

This procedure referred to VIDAS and/or MINIVIDAS service manual.

REMINDER: After the FSE intervention, transmit all data to GCS.

2. Investigation at Customer site

To determine the appropriate root cause, the FSE must perform a troubleshooting step by step.
Depending of QCV value obtained by customer (TV1 issue, R3 issue, TV1 and R3 issue) follow the
appropriate chapter.

FSE must use the service manual procedures to repair. Depending of the root cause, apply the
appropriate procedure

2.1. Troubleshooting for TV1 issue

On one position (2 of 3 QCV tests failed on the same position)

o Visual inspection
o Pump seals on retainer plates
o Visual inspection of the seals (unstuck dot, crystallization, misplaced or stuck dots,
wreckage, fibers and aluminum particles)
o Visual inspection on the tray, on the door, on the shield insulate plate, on the bottom of
the frame)
o Check if doors are hard to close (possible root cause of unstuck dots)

o Check pump and clean it if needed

o Perform a VIDAS Pump Tester and check results.
o Clean the pump position where the VPT Values are under 140 (used VIDAS Pump
Cleaner)
o If needed replace the pump assembly

o Check mechanical part and perform alignment if needed

o Check each SPR spring individually by pressing it completely. When pressing,
movement should be smooth and without stiff point, check if each spring comeback in
the correct position.
o Check the section alignments: tower/pump block, SPR block and tray.

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 o Check the error messages from system :
o In the event viewer for VIDAS PC
o By Typing “errs” command on PuTTY Terminal for Mini VIDAS.

o Check leak presence:

o Replace seals if needed
o Perform the ‘New LEAK’ Test. It will reveal leaks that can be due to a damaged pump
assembly (pump diaphragms, springs, and seals).

2.2. Troubleshooting for R3 issue

o Check the reading system by performing an optical check

o If needed, perform an optical calibration

2.3. Troubleshooting for R3 and TV1 issues

o Perform the same steps as part : “2.1 Troubleshooting for TV1 issue”

2.4. Root cause

Here the most common root causes list of QCV alert :

o The pump either clogged or very near to be clogged

o Pump malfunction
o Dots (or other blocking elements) on the seal
o General misalignment (door, tray, section)
o Scanner head failure
o Important leakages (damaged Seals, pump damaged)

Note: When replacing a spare part please refer to the instructions list “Qualification vs FSE
intervention.xls” present in Service Manual external documents.

3. Field Service Engineer Report

During FSE’s intervention, please use the following document to gather all technical information,
then send it back immediately to GCS department (by CRM/SAP or by email):

FSE REPORT.xlsx

The FSE must complete the FSE report according to which value was out of range in the QCV alert.
The FSE report must be written in English and copied into the CRM case/SAP notification, or through
any other type of tool used to communicate these incidents with the GCS (i.e. email to GCS
address).
Refer to section “How to use this document” in FSE Report to have more information’s

All information from FSE visit must be provided to GCS as soon as possible and within 10 calendar
days from the complaint opening.

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4. bioMérieux recommendation

The FSE role is to perform a reminder of the bioMérieux recommendation to the customer, when it’s
needed.

Responsibilities reminder :

o bioMérieux cannot guarantee that reagent performances claimed into Package Inserts are
reached, if the maintenance procedures performed by our local representative or the customer
are not respected as recommended in the User Manual:

o A Preventive Maintenance should be performed once a year.

o The QCV should be performed every week (for clinical/blood banks) or every month (For
industry/vet/pharma).
o The customer should performs the user maintenances, following bioMérieux User Manual

o Subsidiaries and distributors have the responsibility of raising awareness on the

importance of the above and inform and help the customer to perform a retrospective
analysis

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