BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1032585 · Received April 21, 2008

    Report

    Report Number
    1823260-2008-03442
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTS DISCREPANT SODIUM AND POTASSIUM RESULTS. APPROXIMATE VALUES FOR TWO PTS PROVIDED. PT 1, INITIAL SODIUM RESULT - 10 MMOL/L REPEATED AS NORMAL VALUE. PT2, INITIAL POTASSIUM RESULT 1000 MMOL/L, REPEATED AS NORMAL VALUE. INITIAL RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP DETERMINED A CLOGGED SIPPER NOZZLE TO BE THE CAUSE AND HE FLUSHED THE SIPPER NOZZLE. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYTICS CORE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS MODULAR CORE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK