BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 3527906 · Received December 19, 2013

    Report

    Report Number
    2245578-2013-00244
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    December 16, 2013
    Report Date
    December 17, 2013
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    MMI
    PMA / PMN Number
    K031739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT RESULT OF 0.35 ON A (B)(6) YEAR OLD MALE PATIENT PRESENTED WITH SHORTNESS OF BREATH. THERE WAS NO ADDITIONAL PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. DATE: (B)(6) 2013, TIME: 17:31, RESULT: 0.35 NG/ML; (B)(6) 2013, 17:45, 0.04 NG/ML; (B)(6) 2013, 17:58, 0.04 NG/ML. THERE WERE NO INJURIES REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665812 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE NA R13232

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR