BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1022205 · Received March 26, 2008

    Report

    Report Number
    1823260-2008-02818
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT WITH DISCREPANT GLUCOSE RESULTS. INITIAL RESULT GAVE 9 MG/DL; SAME SAMPLE REPEATED THREE TIMES GIVING 11, 91, AND 94 MG/DL RESPECTIVELY. ERRONEOUS RESULTS WERE REPORTED. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE THE ROOT CAUSE. 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 77 YR