BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL D MODULE

    MDR report key: 1040404 · Received May 7, 2008

    Report

    Report Number
    1823260-2008-03831
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    April 11, 2008
    Report Date
    May 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THREE PT SAMPLES WITH DISCREPANT CALCIUM RESULTS. SAMPLE 1, INITIAL RESULT 6.7 MG/DL, REPEAT 8.8 MG/DL. SAMPLE 2, INITIAL RESULT 6.3 MG/DL, REPEAT 7.9 MG/DL. SAMPLE 3, INITIAL RESULT 5.3 MG/DL, REPEAT 8.8 MG/DL. INITIAL RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP DETERMINED THERE WAS DEBRIS ON THE STIR PADDLE. THE STIR PADDLES, PROBE AND CHANNEL WERE CLEANED. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL D MODULE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS CORP. D MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK