BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL D MODULE

    MDR report key: 1032945 · Received April 23, 2008

    Report

    Report Number
    1823260-2008-03478
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PT SAMPLE WITH DISCREPANT GLUCOSE, ALKALINE PHOSPHATASE, AND TOTAL BILIRUBIN RESULTS. ALL REPEAT TESTING ON DIFFERENT ANALYZER, SAME METHODOLOGY. INITIAL GLUCOSE RESULT 1 MG/DL, REPEAT 97 MG/DL. INITIAL ALKALINE PHOSPHATASE 1 U/L, REPEAT 128 U/L. INITIAL TOTAL BILIRUBIN 0.0 MG/DL, REPEAT 0.3 MG/DL. INITIAL RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP DETERMINED A DEFECTIVE PROBE TO BE THE CAUSE. THE TUBING WAS REFLARED AND THE PROBE WAS REPLACED AND ADJUSTED. PERFORMANCE TEST PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK