BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL D MODULE

    MDR report key: 1051581 · Received May 19, 2008

    Report

    Report Number
    1823260-2008-04137
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 26, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER REPORTS RECEIVING DISCREPANT PT CALCIUM RESULTS STARTING APRIL 23, 2008 FOR MULTIPLE PT SAMPLES. ONLY THE FOLLOWING FIVE PT EXAMPLES WERE PROVIDED, WHICH OCCURRED IN 2008. PT 1, INITIAL RESULT GAVE 4.5 MG/DL; REPEAT GAVE 9.5 MG/DL. PT 2, INITIAL RESULT GAVE 6.8 MG/DL; REPEAT GAVE 8.8 MG/DL. PT 3, INITIAL RESULT 2.3 MG/DL; REPEAT GAVE 10.0 MG/DL. PT 4, INITIAL RESULT GAVE 6.0 MG/DL; REPEAT GAVE 8.5 MG/DL. PT 5, INITIAL RESULT GAVE 7.8 MG/DL; REPEAT GAVE 9.0 MG/DL. NO ERRONEOUS RESULTS WERE REPORTED. THE FIELD SVC REP DETERMINED THE CAUSE OF THE DISCREPANT RESULTS TO BE DUE TO REAGENT BUILDUP ON REAGENT NOZZLE 11, AND CLEANED ALL REAGENT NOZZLES. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPEC.

    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