BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS TAQMAN 48 ANALYZER

    MDR report key: 1628366 · Received March 11, 2010

    Report

    Report Number
    2243471-2010-00007
    Event Type
    Malfunction
    Date Received
    March 11, 2010
    Date of Event
    February 22, 2010
    Report Date
    February 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS LTD.
    Product Code
    JJF
    PMA / PMN Number
    K012966
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPUTER SOFTWARE PERFORMANCE TESTS CONDUCTED, ALGORITHM ANALYSIS, SOFTWARE / FIRMWARE CAUSED EVENT, UNUSUAL EVENT. THE INVESTIGATION DETERMINED THAT THE DISCREPANT TARGET NOT DETECTED (TND) RESULT WAS CAUSED BY THE BASELINE NORMALIZATION CALCULATION OF THE ELTH ALGORITHM. IN VERY RARE INSTANCES, THE ANALYSIS CURVES OF THE AFFECTED SAMPLES ARE NOISY IN THE FIRST FEW CYCLES. THE (B)(4) CURVES DID NOT HAVE ENOUGH VALID BASELINE POINTS FOR A CORRECT CALCULATION OF THE BASELINE. THEREFORE, THE DATA POINTS OF THE PLATEAU REGION WERE INCORRECTLY USED FOR THE CALCULATION OF THE BASELINE, LEADING TO AN INCORRECT TND RESULT. ALL AFFECTED ROCHE MOLECULAR SYSTEMS ASSAYS WERE ASSESSED FOR RISKS AND POSSIBLE IMPACTS DUE TO THE ELTH BASELINE NORMALIZATION ANOMALY. ALL POTENTIAL FAILURE MODES WERE ANALYZED. THE ANOMALY HAS AN EXTREMELY LOW RATE OF OCCURRENCE. (B)(4). ALL RESIDUAL RISKS IDENTIFIED WERE DETERMINED TO BE IN THE ACCEPTABLE OR ALARP (AS LOW AS REASONABLY PRACTICAL) RANGE. THE OVERALL RESIDUAL RISK WAS DETERMINED TO BE ACCEPTABLE WITH NO MAJOR IMPACT ON ASSAY OR SYSTEM PERFORMANCE EXPECTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS ISSUE IS CURRENTLY UNDER INVESTIGATION. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER IN THE U.S. REPORTED THAT THEY RECIEVED A (B)(6) PATIENT SAMPLE RESULT FOR (B)(6) WHILE USING THE KIT C-TAQ HBV 48 TESTS US-IVD (P/N 03577163190; LOT M03237) WITH THE COBAS TAQMAN 48 ANALYZER (P/N 03279332001 S/N 2416) WITH AMPLILINK SOFTWARE V.3.2.2 (P/N 05021357001). THE RESULT THAT THE SOFTWARE REPORTED WAS (B)(6). HOWEVER, THE FLOURESCENCE AMPLIFICATION CURVE SHOWS THAT THE SAMPLE HAD (B)(6). WHEN THE SAMPLE WAS RE-RUN, THE TITER WAS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS TAQMAN 48 ANALYZER ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE JJF ROCHE DIAGNOSTICS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1