BEUDAMED
    FDA Adverse Event Other Summary report: N

    I-STAT CTNI CARTRIDGE

    MDR report key: 820419 · Received February 9, 2007

    Report

    Report Number
    2245578-2007-00005
    Event Type
    Other
    Date Received
    February 9, 2007
    Date of Event
    January 22, 2007
    Report Date
    February 9, 2007
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IN 2007, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT I-STAT CARDIAC TROPONIN I CARTRIDGE YIELDED A RESULT OF 0.32 NG/ML. A SAMPLE WHICH WAS DRAWN AT THE SAME TIME, YIELDED A CARDIAC TROPONIN I RESULT OF 0.01 NG/ML ON A LAB ANALYZER. THE I-STAT RESULT OF 0.32 NG/ML CONTRIBUTED TO THE DECISION TO SENT THE PT FOR CARDIAC CATHETERIZATION. TEST RESULTS FROM THE CARDIAC CATHETERIZATION WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CTNI CARTRIDGE IVD MMI ABBOTT POINT OF CARE INC. NA U06283A

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other