BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1193365 · Received October 7, 2008

    Report

    Report Number
    1823260-2008-07392
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 16, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED ERRONEOUS RESULTS FOR TROPONIN T FOR ONE PATIENT SAMPLE. INITIAL RESULT 0.063 NG/ML, REPEAT GAVE 0.026 NG/ML, 0.023 NG/ML AND 0.020 NG/ML. INITIAL RESULT WAS NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE, BUT NOTED HE CHECKED THE ANALYZER. HE FOUND THE HIGH VOLTAGE WAS LOW OUTSIDE OF LIMITS AND ADJUSTED IT UP TO PROPER LEVEL. PERFORMANCE TESTS WERE PERFORMED.

    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 73 YR