BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CTNI CARTRIDGE

    MDR report key: 1051526 · Received May 23, 2008

    Report

    Report Number
    2245578-2008-00027
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 24, 2008
    Report Date
    May 14, 2008
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS PRODUCT MEETS THE CRITERIA FOR A 5-DAY MDR AS DESCRIBED IN THE FDA'S NOTICE DATED APRIL 8, 2008 [TO MANUFACTURERS AND INITIAL DISTRIBUTORS OF MEDICAL DEVICES THAT MAY CONTAIN HEPARIN OR ARE HEPARIN - COATED], AND ABBOTT IS SUBMITTING THIS 5-DAY MDR. OUR INVESTIGATION INTO THIS EVENT IS ONGOING AND A SUPPLEMENTAL MDR WILL BE SUBMITTED AT THE CONCLUSION OF OUR INVESTIGATION. ON 04/24/2008, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED AN I-STAT CARDIAC TROPONIN I CARTRIDGE YIELDED A RESULT OF 21.75 NG/ML. SAME SAMPLE TESTED USING A LABORATORY SYSTEM YIELDED A RESULT OF 1.22 NG/ML. SECOND SAMPLE TESTED USING AN I-STAT CARDIAC TROPONIN I CARTRIDGE YIELDED A RESULT OF 20.81 NG/ML. ON A DIFFERENT I-STAT INSTRUMENT, REPORTED AN I-STAT CARDIAC TROPONIN I CARTRIDGE YIELDED A RESULT OF 22.96 NG/ML. SAME SAMPLE TESTED USING A LABORATORY SYSTEM YIELDED A RESULT OF 1.44 NG/ML. THIRD SAMPLE TESTED USING AN I-STAT CARDIAC TROPONIN I CARTRIDGE YIELDED A RESULT OF 33.09 NG/ML. ON A DIFFERENT LOT NUMBER U08022 (2245578-2008-00028) REPORTED AN I-STAT CARDIAC TROPONIN I CARTRIDGE YIELDED A RESULT OF 27.11 NG/ML. SAME SAMPLE TESTED USING A LABORATORY SYSTEM YIELDED A RESULT OF 1.290 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CTNI CARTRIDGE IVD MMI ABBOTT POINT OF CARE INC. NA U08044

    Patients

    Seq Age Sex Outcome Treatment
    1