BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1040405 · Received May 7, 2008

    Report

    Report Number
    1823260-2008-03832
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    February 1, 2008
    Report Date
    May 7, 2008
    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

    COMPARISON OF TROPONIN T MEDIAN VALUES FOR SIX EXTERNAL PROFICIENCY SURVEY SAMPLES BETWEEN TWO DIFFERENT LOT NUMBERS OF TROPONIN T REAGENT. ONE SURVEY SET TESTED IN FEBRUARY GAVE THE FOLLOWING RESULTS WHICH ARE CALCULATED MEDIAN RESULTS. #1, INITIAL RESULT GAVE 0.90 NG/ML; REPEAT GAVE 1.09 NG/ML. #2, INITIAL RESULT GAVE 0.17 NG/ML; REPEAT GAVE 0.22 NG/ML. #3, INITIAL RESULT GAVE 0.070 NG/ML; REPEAT GAVE 0.106 NG/ML. SECOND SET TESTED IN MARCH GAVE THE FOLLOWING CALCULATED MEDIAN RESULTS: #4, INITIAL RESULT GAVE 0.04 NG/ML; REPEAT GAVE 0.06 NG/ML. #5, INITIAL RESULT GAVE 0.100 NG/ML; REPEAT GAVE 0.134 NG/ML. #6, INITIAL RESULT GAVE 0.173 NG/ML; REPEAT GAVE 0.22 NG/ML. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    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