BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1052523 · Received May 22, 2008

    Report

    Report Number
    1823260-2008-04256
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 4, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT SAMPLE WITH DISCREPANT SODIUM RESULTS. INITIAL RESULT GAVE 130 MMOL/L; REPEAT GAVE 137 MMOL/L. ERRONEOUS RESULT WAS NOT REPORTED. THE FIELD SERVICE REP DETERMINED THE CAUSE FOR THE DISCREPANCY TO BE THE AIR DRY WAS INCORRECTLY SET, DUE TO A LOOSE JAM NUT, A SET AIR DRY AND MIX TO PROPER SPECIFICATION. PERFORMANCE TESTS WERE PERFORMED.

    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