BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADDITIONAL P MODULE

    MDR report key: 1761251 · Received July 20, 2007

    Report

    Report Number
    1823260-2007-06342
    Event Type
    Malfunction
    Date Received
    July 20, 2007
    Date of Event
    June 30, 2007
    Report Date
    July 20, 2007
    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

    ACCOUNT STATES THEY ARE GETTING ERRATIC RESULTS FOR VARIOUS ASSAYS. TWO CREATININE PATIENT RESULTS WERE PROVIDED: SAMPLE 1 INITIAL 3.4 MG/DL, MANUAL REPEAT 0.6 MG/DL. INCORRECT RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANT RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA