BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1070479 · Received July 7, 2008

    Report

    Report Number
    1823260-2008-05222
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    June 10, 2008
    Report Date
    July 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    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

    USER EXPERIENCING DISCREPANT CALCIUM RESULTS OVER A PERIOD OF 3 DAYS. THE FOLLOWING DATA WAS PROVIDED, RESULTS IN MG/DL, RESULTS LISTED AS INITIAL/REPEAT: ERRONEOUS RESULTS WERE REPORTED, PATIENTS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE HIGH CONCENTRATION WAS VALVE AND BOTTLE WERE CLOGGED AND CLEANED THE BOTTLE AND VALVE. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK