BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS TAQMAN ANALYZER

    MDR report key: 562502 · Received May 13, 2004

    Report

    Report Number
    2243471-2004-00002
    Event Type
    Malfunction
    Date Received
    May 13, 2004
    Date of Event
    April 13, 2004
    Report Date
    May 13, 2004
    Manufacturer
    ROCHE INSTRUMENT CENTER AG
    Product Code
    JJF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2004 THE CUSTOMER REPORTED TO ROCHE DIAGNOSTICS CORPORATION TECHNICAL SUPPORT HIGH OUT OF RANGE HEPATITIS B CONTROL VALUES AND ELEVATED PT VALUES ON THE COBAST TAQMAN ANALYZER THERMAL CYCLER C (3). A FIELD SERVICE REP HAD REPLACED THE ANALYZER EXITATION LAMP ON THE FOLLOWING DAY AND THERMAL CYCLER C (3) ON THE DAY AFTER. NO FALSELY ELEVATED HBV VALUES OR CONTROLS HAVE BEEN REPORTED SINCE THE TC WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS TAQMAN ANALYZER MICRO CHEMISTRY ANALYZER FOR NUCLEIC ACID TESTING JJF ROCHE INSTRUMENT CENTER AG SERIES 96 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other