Problem solving procedure for 12-cell cuvettes

Please check the following tasks before contacting the supplier (See the contact instructions at the end
of this document). Go through this form step by step and try to examine the root cause of the feedback.

Cuvette issues to be checked:

Original, disposable cuvettes in use
No finger prints (if high water blank)
No dust (if high water blank)
Cuvette storage has been appropriate (see package label for storage conditions)
No prints/markings etc from the tape
Cuvette visual check OK

Instrument issues to be checked:

If the cuvette feedback is about high water blank:
Canister water quality check: Type I water, no contamination, weekly wash performed, no air bubbles
No air in the water tubing and syringe. If yes, action: Prime the tubing to remove the air.
Check for possibility of needle block /extra material dispensed to the water cuvette. Clean the
needle, Perform extra water wash.
Check for dust in the incubator. Clean weekly.
Check only if needed: Filters (position, lifetime), halogen lamp
Check/evaluate that the cuvette position adjustments are correct

Also in other cases:

Check/evaluate the mechanical adjustments for the cuvette.
- Too tight adjustments can cause cuvette acrylic dust if high water blank
- Too tight adjustments can cause jamming of the cuvettes

SW issues to be considered:
Update the sw to the level 6.5. In this version, cuvette blank can be checked without the water and
interaction of the needle

If these procedures have not solved the problem, please proceed to the following cuvette
feedback form.

1
Cuvette feedback form for root cause analysis
These cuvettes have passed through tight quality control procedures to ensure high product quality. In
case you do have problems related to use of the cuvettes, you need to fill in this feedback form to find
the true source of problem. After that, proper actions can be taken to avoid recurrence of the problem.

Cuvette feedback must always be connected to the cavity information (like 63, 72 or K1) and the
manufacturing date (like 050302 1 or 5061K0). This information is vital for the feedback handling and
root cause analysis and is needed for any compensation process.

Cuvette Cavity (only one cavity per 984000 box): ________

Cuvette manufacturing date (see the plastic bag sticker, like 050302 1 or 5061K0, can be several dates
per 984000 box):__________________________________________________

Analyzer serial number:________________________________________________________

Sw version in use:____________________________________________________________

Location (customer) of the analyzer:______________________________________________

Tests in use:________________________________________________________________

___________________________________________________________________________

Details of the cuvette problem (when/what/how) (please enclose analyzer sw printouts if possible):
___________________________________________________________________________

___________________________________________________________________________

___________________________________________________________________________

Is this a occasional or systematic problem? If systematic please specify recurrence:

__________________________________________________________________________

Last analyzer service date / by whom:____________________________________________

Service agreement:___________________________________________________________

Other remarks:

Has this problem caused risks for wrong patient/sample results causing death of serious injury? If yes
relevant documentation is attached and the manufacturer is contacted immediately.

Fax this letter to manufacturer Thermo Electron CC&A Service or contact your local service CC&A Service fax: +358-9-32910300

Document version 17062005 NBR/ASU/AP