BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 2199806 · Received August 2, 2011

    Report

    Report Number
    2245578-2011-00122
    Event Type
    Malfunction
    Date Received
    August 2, 2011
    Date of Event
    July 11, 2011
    Report Date
    August 2, 2011
    Manufacturer
    ABBOTT POINT OF CARE CANADA LTD.
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT ARE YIELDING DISCREPANT RESULTS IN THE ED USING MULTIPLE ANALYZERS. ON (B)(6) 2011 19:56, RESULT: 0.09 NG/ML. ON (B)(6) 2011 20:14, RESULT 0.00 NG/ML. ON (B)(6) 2011 20:35, RESULT: 0.0 (UNKNOWN DUE TO ILLEGIBLE PRINT ON CUSTOMER INFORMATION RECEIVED). THE SUSPECTED DISCREPANT RESULT WAS RELEASED TO THE PHYSICIAN. SAMPLE WAS RUN IN THE MAIN LAB. ON (B)(6) 2011 20:11, RESULT: 0.01 NG/ML. BASED ON THE INFORMATION AVAILABLE AT THE TIME, 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 T11096

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK