BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1080641 · Received July 22, 2008

    Report

    Report Number
    1823260-2008-05644
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PT WITH DISCREPANT TOTAL BILIRUBIN RESULTS. INITIAL RESULT 1.24 MG/DL, REPEAT 14.6 MG/DL. ERRONEOUS RESULT WAS NOT REPORTED. FIELD SERVICE REP DETERMINED ROOT CAUSE TO BE SAMPLE TUBES LEANING IN THE RACK AND INSTALLED CUP ADAPTERS INTO THE RACKS. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK