BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXSYM TROPONIN-I ADV REAGENT

    MDR report key: 603261 · Received May 17, 2005

    Report

    Report Number
    1415939-2005-00018
    Event Type
    Other
    Date Received
    May 17, 2005
    Date of Event
    April 17, 2005
    Report Date
    May 17, 2005
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PT GENERATED AN INITIAL AXSYM TROPNIN-I ADV ASSAY RESULT OF 1.16 NG/ML (CKMB = 1.6 NG/ML, TOTAL CK = 27 U/L). SIX HOURS LATER, ANOTHER SAMPLE WAS DRAWN AND GENERATED AN AXSYM TROPONIN-I ADV ASSAY REUSLT OF 1.58 NG/ML (CKMB = 1.0 NG/ML). APPROXIMATELY SEVEN HOURS LATER, A NEW SAMPLE GENERATED AN AXSYM TROPONIN-I ADV ASSAY RESULT OF 1.54 NG/ML (CKMB = 0.8 NG/ML, TOTAL CK = 10 U/L). CONTROLS WERE WITHIN SPECIFICATIONS ON ALL RUNS. THE PT WAS TRANSFERRED TO ANOTHER FACILITY AND A CARDIAC CATHETERIZATION WAS PERFORMED THAT INDICATED NO CARDIAC INVOLVEMENT. THE CUSTOMER USED A TROPONIN-I CUTOFF OF LESS THAN 0.4 NG/ML. PT HAS BEEN DISCHARGED WITH NO OTHER IMPACT TO PT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM TROPONIN-I ADV REAGENT MELA FOR MEASUREMENT OF TROPONIN-I MMI ABBOTT LABORATORIES NA 21581M201

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other