BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1063544 · Received June 20, 2008

    Report

    Report Number
    1823260-2008-04873
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 20, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT WITH DISCREPANT TROPONIN T RESULTS. INITIAL RESULTS NOT REPORTED, PATIENT NOT ADVERSELY AFFECTED. INITIAL RESULTS 0.123 NG/ML, REPEATED TWICE ON SAME ANALYZER, BOTH RESULTS GIVING <0.01 NG/ML. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO FIND A CAUSE FOR THE DISCREPANCY. 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 2010 RACK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK