BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    917 DISK SYSTEM

    MDR report key: 1052519 · Received May 22, 2008

    Report

    Report Number
    1823260-2008-04267
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 5, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT WITH DISCREPANT SODIUM RESULTS. INITIAL RESULT 103 MMOL/L, REPEAT 128 MMOL/L. THE INITIAL RESULT WAS NOT PROVIDED. THE FIELD SERVICE REP DETERMINED THE POSITION OF THE SAMPLE PROBE TO BE THE CAUSE AND HE ADJUSTED THE SAMPLE PROBE POSITION. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 917 DISK SYSTEM CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS 917

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK