BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1780979 · Received July 26, 2007

    Report

    Report Number
    1823260-2007-06564
    Event Type
    Malfunction
    Date Received
    July 26, 2007
    Date of Event
    May 6, 2007
    Report Date
    July 26, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INITIAL RESULT FOR A PATIENT ETHANOL WAS NONE DETECTED. WHEN REPEATED ON A REDRAW, THE RESULT WAS >300 MG/DL. THE ORIGINAL SAMPLE WAS RETESTED AND THE RESULT WAS >300 MG/DL. NO TREATMENT WAS PROVIDED BASED ON THE INCORRECT RESULT. THE FIELD SERVICE REP FOUND THE SAMPLING PRECISION WAS BAD AND REPAIRED THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA