BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1018059 · Received March 14, 2008

    Report

    Report Number
    1823260-2008-02451
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 21, 2008
    Report Date
    March 14, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PT SAMPLE WITH DISCREPANT SODIUM RESULTS. INITIAL RESULT GAVE 132 MMOL/L. SAMPLE REPEATED THREE TIMES GIVING 140, 129 AND 132 MMOL/L. ERRONEOUS RESULT WAS NOT REPORTED. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS I800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK