BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYZER

    MDR report key: 1040401 · Received May 7, 2008

    Report

    Report Number
    1823260-2008-03828
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    April 10, 2008
    Report Date
    May 7, 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

    OPERATOR REPORTS DISCREPANT SODIUM RESULTS WHILE RANDOMLY RUNNING A POOLED PT SAMPLE. INITIAL RESULT 129 MMOL/L. SAME SAMPLE REPEATED THREE TIMES GAVE 142, 141 AND 142 MMOL/L. NO RESULTS REPORTED SINCE THIS WAS A POOLED PT SAMPLE. THE FIELD SERVICE REP DETERMINED THE ISE SAMPLE PROBE TO BE THE CAUSE AND REPLACED THE PROBE. HE ALSO FLUSHED THE ISE 1 FLOW PATH. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPEC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK