BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS TAQMAN 48 ANALYZER

    MDR report key: 1851297 · Received October 4, 2010

    Report

    Report Number
    2243471-2010-00025
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    November 10, 2008
    Report Date
    November 10, 2008
    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

    REVIEW OF THE CUSTOMER DATA SUGGESTS THAT THE FALSE (B)(6) RESULT WAS GENERATED DUE TO A RARE CURVE ANOMALY THAT LEADS TO AN INCORRECT NORMALIZATION OF THE BASELINE BY THE ALGORITHM. HOWEVER, CURVE ANOMALIES COULD STILL OCCUR AND MAY RARELY RESULT IN SUDDEN TITER SHIFTS DUE TO THE SOFTWARE ALGORITHM. PRODUCT BULLETIN 232/2006 INDICATES THAT DIPS IN BASELINES CAN ARISE FROM IMPROPER MIXING OF SAMPLE IN THE WORKING MASTER MIX. IN ADDITION, NOT EQUILIBRATING THE MASTER MIX AND MAGNESIUM REAGENTS TO ROOM TEMPERATURE BEFORE USE CAN ALSO HAVE THE SAME EFFECT. OTHER SAMPLES IN THE SAME RUN EXHIBITED SIMILAR BASELINE DIPS AS SEEN WITH THE SAMPLE RESULT UNDER QUESTION, HOWEVER THEIR LOWER TITER AND LATER CTS DID NOT CONFLICT WITH THE BASELINING ALGORITHM. THE RESULT WAS NOT REPORTED OUT TO THE PHYSICIAN AND THEREFORE IT HAD NO EFFECT ON THE PATIENT TREATMENT. HAD THE ERRONEOUS RESULT BEEN REPORTED, THE RISK TO PATIENT WOULD BE LOW SINCE THE (B)(6) TEST IS INTENDED TO BE USED AS AN AID IN ASSESSING VIRAL RESPONSE TO ANTIVIRAL THERAPY AS MEASURED BY CHANGES IN PLASMA NUCLEIC ACID LEVELS. IN THIS CONTEXT, CHANGES IN THERAPY WOULD NOT BE IMPLEMENTED IF THE TITER WAS ABERRANT FROM PREVIOUS TITERS, THE OVERALL CLINICAL CONDITION AND OTHER CLINICAL PARAMETERS. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) FILED A COMPLAINT CASE ALLEGING A FALSE (B)(6) RESULT WAS GENERATED USING THE HIGH PURE SYSTEM/COBAS (B)(6). THE ERRONEOUS RESULT WAS DISCOVERED WHEN THE CUSTOMER REVIEWED THE GROWTH CURVES AND REALIZED THAT A TARGET NOT DETECTED (TND) RESULT HAD BEEN GENERATED FOR A SAMPLE WITH A (B)(6) NON-NORMALIZED GROWTH CURVE. THE RESULT WAS NOT REPORTED OUT AND THEREFORE IT HAD NO EFFECT ON THE PATIENT TREATMENT.

    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