BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CTNI CARTRIDGE

    MDR report key: 912537 · Received September 13, 2007

    Report

    Report Number
    2245578-2007-00047
    Event Type
    Malfunction
    Date Received
    September 13, 2007
    Date of Event
    August 16, 2007
    Report Date
    September 13, 2007
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    PMA / PMN Number
    K031739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON 8/16/2007, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT AN I-STAT CARDIAC TROPONIN II CARTRIDGE YIELDED A RESULT OF 0.19 NG/ML 2007 01:26. A DIFFERENT SAMPLE WAS TESTED IN THE LABORATORY YIELDING A RESULT OF 0.06NG/ML 3 MONTHS PRIOR 01:19. ANOTHER SAMPLE WAS COLLECTED AND TESTED USING AN I-STAT CARDIAC TROPONIN T CARTRIDGE AND YIELDED A RESULT OF 0.02NG/ML 3 MONTHS LATER 06:00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CTNI CARTRIDGE IVD MMI ABBOTT POINT OF CARE INC. NA U07051B

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR