BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1221502 · Received November 5, 2008

    Report

    Report Number
    1823260-2008-08192
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 15, 2008
    Report Date
    November 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED AN ERRONEOUS TROPONIN T RESULT FOR ONE PATIENT SAMPLE. INITIAL RESULT WAS 0.032 NG/ML, REPEAT RESULTS WERE 0.012 AND 0.013 NG/ML. THE ERRONEOUS RESULT WAS NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE DID NOT FIND A PROBLEM WITH THE ANALYZER. PERFORMANCE TESTS WERE PERFORMED.

    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 84 YR