BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 2210185 · Received May 9, 2011

    Report

    Report Number
    2245578-2011-00062
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 18, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ABBOTT POINT OF CARE CANADA LTD.
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, ABBOTT POINT OF CARE WAS CONTACTED REGARDING AN I-STAT TROPONIN CARTRIDGE THAT YIELDED AN UNEXPECTED RESULT OF 0.14 NG/ML ON A PT WHEN RUNNING LITHIUM HEPARIN PLASMA. REPEAT TEST RESULT ON THE SAME SAMPLE RUNNING WHOLE BLOOD USING THE I-STAT WAS 0.03 NG/ML. BASED ON THE INFO AVAILABLE THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE CANADA LTD. NA T11040

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR