BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 1010

    MDR report key: 1079344 · Received July 18, 2008

    Report

    Report Number
    1823260-2008-05588
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 18, 2008
    Manufacturer
    OCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO PATIENT SAMPLES WITH DISCREPANT TROPONIN T RESULTS. PATIENT 1, INITIAL RESULT GAVE 0.53 NG/ML; REPEATED ONCE IN 2008 GIVING 0.012 NG/ML AND FOUR TIMES IN THE NEXT DAY GIVING 0.014, 0.013, 0.011 AND 0.014 NG/ML. PATIENT 2, INITIAL RESULT GAVE 0.054 NG/ML; REPEAT GAVE 0.209 NG/ML. SAMPLE REPEATED TWICE IN THE NEXT DAY GIVING <0.010 NG/ML EACH TIME. NO ADVERSE EVENTS REPORTED IN ASSOCIATION WITH THE RESULTS. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 1010 IMMUNOCHEMISTRY ANALYZER - JJE MMI OCHE DIAGNOSTICS 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK