BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CTNI CARTRIDGE

    MDR report key: 1202045 · Received September 23, 2008

    Report

    Report Number
    2245578-2008-00073
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    August 25, 2008
    Report Date
    September 23, 2008
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IN 2008, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED AN I-STAT CARDIAC TROPONIN I CARTRIDGE YIELDED A RESULT OF 0.15 NG/ML. SAMPLE, UNKNOWN IF SAME SAMPLE, REPEATED TEST USING AN I-STAT CARDIAC TROPONIN I CARTRIDGE YIELDED A RESULT OF 0.03 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 T08118A

    Patients

    Seq Age Sex Outcome Treatment
    1