BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS MIRA PLUS

    MDR report key: 1070457 · Received July 7, 2008

    Report

    Report Number
    1823260-2008-05229
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    June 17, 2008
    Report Date
    July 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K920402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTS THREE PATIENTS WITH DISCREPANT TOTAL BILIRUBIN RESULTS. SAME SAMPLE REPEAT RESULTS GENERATED FROM ANOTHER LABORATORY, METHODOLOGY UNKNOWN. PATIENT 1, INITIAL RESULT 0.6 MG/DL, REPEAT 0.9 MG/DL. PATIENT 2, INITIAL RESULT 1.1 MG/DL, REPEAT 0.6 MG/DL. PATIENT 3, INITIAL RESULT 0.5 MG/DL, REPEAT 1.1 MG/DL. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS MIRA PLUS CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS MIRA PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK