BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1030627 · Received April 16, 2008

    Report

    Report Number
    1823260-2008-03277
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTS ONE DISCREPANT PT ALCOHOL RESULT. INITIAL RESULT -46 UMOL/L, REPEAT GAVE 58 UMOL/L. THE INITIAL RESULT WAS NOT REPORTED. THE FIELD SERVICE REP DETERMINED THE SAMPLE AND REAGENT PROBES TO BE THE CAUSE. HE CLEANED THE SAMPLE PROBE AND ALIGNED REAGENT PROBES. IN ADDITION, THE TECHNICAL SERVICE REP CORRECTED THE TECHNICAL LOWER LIMIT TO REFLECT THE CORRECT PARAMETERS AS PER LABELING. 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 P MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK