BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL D MODULE

    MDR report key: 1213175 · Received October 23, 2008

    Report

    Report Number
    1823260-2008-07851
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 23, 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 EXPERIENCED DISCREPANT TOTAL BILIRUBIN RESULTS FOR TWO PT SAMPLES. SAMPLE 1, INITIAL RESULT GAVE 0.5 MG/DL; REPEAT GAVE 4.0 MG/DL. SAMPLE 2, INITIAL RESULT GAVE 0.7 MG/DL; REPEAT GAVE 3.5 MG/DL USER STATED THEY REPORTED THE REPEAT RESULTS FOR BOTH PT SAMPLES. PTS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE A PROBLEM WITH THE PT SAMPLES, NOTING HE CHECKED THE SYSTEM WITH NO PROBLEMS FOUND. PERFORMANCE TESTS WERE PERFORMED.

    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