BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXSYM TROPONIN-I

    MDR report key: 496519 · Received November 12, 2003

    Report

    Report Number
    1415939-2003-00030
    Event Type
    Other
    Date Received
    November 12, 2003
    Date of Event
    October 8, 2003
    Report Date
    November 12, 2003
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED AXSYM TROPONIN-I RESULTS OF 6.3 NG/ML (PLASMA SPECIMEN) AND 6.2 NG/ML (SERUM SPECIMEN) ON A PT. THE NEXT DAY, THE PT TESTED AXSYM TROPONIN-I OF 5.8 NG/ML AND EKG SHOWED SOME Q WAVES IN LEAD III AND AVF. A CHEST X-RAY WAS PERFORMED SHOWING CHRONIC INTERSTITIAL CHANGES AND POSSIBLY SOME CARDIOMEGALY. THE PT UNDERWENT A CARDIAC CATHETERIZATION AND THE FINDINGS WERE NORMAL. IN ADDITION, A NON-ABBOTT TROPONIN-T ASSAY WAS PERFORMED AND THE RESULT WAS 0 (NO UNITS OF MEASUREMENT GIVEN). NO FURTHER IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM TROPONIN-I MEIA FOR THE MEASUREMENT OF TROPONIN-I MMI ABBOTT LABORATORIES NA 07558M100

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other AXSYM ANALYZER LIST 7A83-01.