BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 1083171 · Received July 24, 2008

    Report

    Report Number
    1823260-2008-05764
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PT WITH DISCREPANT SODIUM RESULTS. INITIAL RESULT 134 MMOL/L, REPEAT 140 MMOL/L. ERRONEOUS RESULT WAS REPORTED. PT NOT ADVERSELY AFFECTED. FIELD SVC REP DETERMINED THERE WAS A PROBLEM WITH THE SODIUM ELECTRODE. THE ELECTRODE WAS REPLACED. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK