BEUDAMED
    FDA Adverse Event Other Summary report: N

    I-STAT CTNI CARTRIDGE

    MDR report key: 955795 · Received April 18, 2007

    Report

    Report Number
    2245578-2007-00010
    Event Type
    Other
    Date Received
    April 18, 2007
    Date of Event
    March 20, 2007
    Report Date
    April 18, 2007
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON 03/21/2007 ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT A PATIENT WAS TREATED WITH A LOW MOLECULAR WEIGHT HEPARIN PRODUCT BASED ON AN I-STAT CARDIAC TROPONIN I CARTRIDGE RESULT OF 0.88NG/ML. THE CUSTOMER REPORTED TESTING A NEW SAMPLE 90 MINUTES LATER WHICH YIELDED A CARDIAC TROPONIN I RESULT OF 0.01NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CTNI CARTRIDGE IVD JJE ABBOTT POINT OF CARE INC. NA U06277

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other