BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1080657 · Received July 22, 2008

    Report

    Report Number
    1823260-2008-05653
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PT SAMPLE WITH DISCREPANT SODIUM RESULTS. INITIAL RESULT GAVE 125 MMOL/L; SAMPLE REPEATED TWICE GIVING 130 AND 134 MMOL/L. INITIAL RESULT WAS REPORTED. PT NOT ADVERSELY AFFECTED. THE FIELD SVC REP WAS UNABLE TO DUPLICATE THE ISSUE. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS C501

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR