BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1082536 · Received July 23, 2008

    Report

    Report Number
    1823260-2008-05688
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    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

    ONE PATIENT WITH DISCREPANT CKMB RESULTS. INITIAL RESULT 3 NG/ML, REPEAT RESULT 4 NG/ML. INITIAL RESULT WAS NOT REPORTED. FIELD SERVICE REP DETERMINED ROOT CAUSE WAS A DEFECTIVE MEASURING CELL AND REPLACED THE MEASURING CELL. PERFORMANCE TESTS WERE PERFORMED AND WERE WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK