BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2010 RACK ELECSYS

    MDR report key: 1772087 · Received November 1, 2007

    Report

    Report Number
    1823260-2007-09507
    Event Type
    Malfunction
    Date Received
    November 1, 2007
    Date of Event
    October 17, 2007
    Report Date
    October 31, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO PATIENT SAMPLES WITH DISCREPANT TROPONIN T RESULTS. SAMPLE 1: INITIAL RESULT 0.77 NG/ML, REPEAT <0.010 NG/ML. SAMPLE 2, INITIAL RESULT 0.78 NG/ML, REPEAT <0.010 NG/ML. THE INITIAL RESULTS WERE NOT REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK