BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1053003 · Received May 27, 2008

    Report

    Report Number
    1823260-2008-04301
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT WITH DISCREPANT CREATININE RESULTS. INITIAL RESULT 0.2 MG/DL, REPEAT 3.0 MG/DL. THE INITIAL RESULT WAS NOT REPORTED. THE FIELD SERVICE REP DETERMINED THE DE-GASSED WATER PRESSURE WAS LOW AND THE VACUUM PUMP DIAPHRAGM NEEDED TO BE REPLACED. HE REPLACED THE GEAR PUMP HEAD, SV40 VALVE AND THE DIAPHRAGM. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPEC.

    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