BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 2142636 · Received June 21, 2011

    Report

    Report Number
    2245578-2011-00088
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 16, 2011
    Manufacturer
    ABBOTT POINT OF CARE CANADA LTD.,
    Product Code
    MMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CARTRIDGE LOT INFORMATION PROVIDED ON (B)(4) 2011: LOT #: T11075, MANUFACTURE DATE: 03/16/2011, EXPIRATION DATE: 10/14/2011.

    Description of Event or Problem · 1

    ON (B)(6) 2011, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING AN I-STAT TROPONIN CARTRIDGE THAT YIELDED A POTENTIAL FALSE POSITIVE RESULT ON A PATIENT. ON (B)(6) 2011, THE FOLLOWING RESULTS WERE OBTAINED: 2.47 NG/ML ON THE I-STAT (LOT# T11054), 2.43 NG/ML ON THE I-STAT, SAME SAMPLE (LOT# T11075), 4.97 NG/ML ON THE SIEMENS VISTA (SPUN DOWN, RAN PLASMA). PATIENT WAS SENT TO CATH LAB FOR BALLOON PROCEDURE BASED ON CTNI 2.47. PHYSICIAN IS QUESTIONING ALL RESULTS BECAUSE THE CARDIAC CATH DID NOT SHOW SIGNS OF A POSITIVE TROPONIN RESULT. THE CUSTOMER FEELS THAT HETEROPHILE ANTIBODIES ARE A STRONG CASE FOR THE OBSERVED ISSUE AFTER DISCUSSIONS WITH THE PATHOLOGIST. BASED ON THE INFORMATION 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 T11054

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK