BEUDAMED
    FDA Adverse Event Other Summary report: N

    I-STAT CTNI CARTRIDGE

    MDR report key: 906955 · Received August 30, 2007

    Report

    Report Number
    2245578-2007-00028
    Event Type
    Other
    Date Received
    August 30, 2007
    Date of Event
    July 12, 2007
    Report Date
    August 30, 2007
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    PMA / PMN Number
    K031739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2007, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT AN I-STAT CARDIAC TROPONIN I CARTRIDGE YIELDED A RESULT OF 0.27 NG/ML OR A PT AT 21:45 ABOUT 3 WEEKS BEFORE. THE PT WAS TRANSFERRED TO ROYAL MELBOURNE HOSPITAL WHERE A SAMPLE GENERATED A TROPONIN I RESULT OF <0.01 NG/ML USING AN UNK METHOD. THE I-STAT RESULT OF 0.27 NG/ML CONTRIBUTED TO THE DECISION TO PERFORM AND ANGIOGRAM ON THE PT. TEST RESULTS FROM THE ANGIOGRAM 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 U07105

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other