BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS AMPLIPREP/ COBAS TAQMAN 48 WITH AMPLILINK SOFTWARE V 3.2.2

    MDR report key: 1678576 · Received May 11, 2010

    Report

    Report Number
    2243471-2010-00026
    Event Type
    Malfunction
    Date Received
    May 11, 2010
    Date of Event
    April 13, 2010
    Report Date
    July 26, 2010
    Manufacturer
    ROCHE DIAGNOSTICS LTD.
    Product Code
    JJF
    PMA / PMN Number
    K012966
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE IS UNDER EVALUATION. IT IS THOUGHT THAT THE CAUSE OF THE DISCREPANT RESULT IS LIKELY DUE TO DIRTY THERMAL CYCLER WELLS OF THE CUSTOMER'S COBAS TAQMAN ANALYZER, WHICH PRODUCED LOW FLUORESCENCE INTENSITIES, RESULTING IN A VERY LOW BASELINE. HOWEVER, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED THAT THEY RECEIVED AN ERRONEOUS RESULT WITH THE COBAS AMPLIPREP / COBAS TAQMAN HCV TEST US-IVD (M/N 03568555190 BATCH M14026). THE CUSTOMER STATED THAT A SAMPLE PRODUCED A RESULT BASED ON A SPIKE AT CYCLE 6 VS. THE ACTUAL AMPLIFICATION CURVE WHEN DID NOT COME UP UNTIL APPROXIMATELY CYCLE 28. THE SAMPLE GENERATED A RESULT OF >69,000,000 IU/ML. UPON REPEAT, THE SAMPLE RESULT WAS 88,000 IU/ML. THE CUSTOMER REPORTED BOTH RESULTS TO THE PHYSICIAN, ABOUT 36 HOURS APART. HOWEVER, THERE WAS NO CHANGE / EFFECT ON PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS AMPLIPREP/ COBAS TAQMAN 48 WITH AMPLILINK SOFTWARE V 3.2.2 ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE JJF ROCHE DIAGNOSTICS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1