BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1213184 · Received October 23, 2008

    Report

    Report Number
    1823260-2008-07841
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    October 2, 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 GLUCOSE RESULTS FOR ONE PATIENT SAMPLE. INITIAL RESULT GAVE 9 MG/DL; REPEAT GAVE 33 MG/DL. CUSTOMER REPORTED THE REPEAT GLUCOSE RESULT OF 33 MG/DL. NO PATIENT TREATMENT WAS INCURRED BASED ON THIS RESULT. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE THE SAMPLE PROBE WAS CLOGGED WITH FIBRIN AND CLEANED THE SAMPLE PROBE. PERFORMANCE TESTS WERE PERFORMED.

    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