BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1082723 · Received July 23, 2008

    Report

    Report Number
    1823260-2008-05718
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    TWO PATIENTS WITH DISCREPANT CKMB RESULTS. PATIENT 1, INITIAL RESULT 38 NG/ML, REPEAT 20NG/ML. PATIENT 2, INITIAL RESULT 19 NG/ML, REPEAT PERFORMED BY ALTERNATE METHODOLOGY GAVE 10.6 NG/ML. INITIAL RESULT WAS NOT REPORTED. FIELD SERVICE REP DETERMINED ROOT CAUSE WAS DEFECTIVE MEASURING CELL AND REPLACED THE MEASURING CELL. PERFORMANCE TESTS WERE PERFORMED AND WERE WITHIN SPEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR