BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1231143 · Received November 12, 2008

    Report

    Report Number
    1823260-2008-08345
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    November 3, 2008
    Report Date
    November 12, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED A DISCREPANT TROPONIN T RESULT FOR ONE PT SAMPLE. INITIAL RESULT WAS 0.147 NG/ML, REPEAT RESULTS WERE 0.039 AND 0.038 NG/ML. THE REPEATED RESULT WAS REPORTED OUT SO THERE WAS NO PT TREATMENT FROM THE FIRST RESULT. THE SECOND RESULT IS SLIGHTLY ELEVATED BUT THEY HAVE NO KNOWLEDGE OF ANY PT TREATMENT. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE A CAUSE AND PERFORMED INSTRUMENT CHECKS. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    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 UNK