BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 3003797 · Received March 14, 2013

    Report

    Report Number
    2245578-2013-00026
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 22, 2013
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    MMI
    PMA / PMN Number
    K031739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON 03/08/2013. CUSTOMER RETURNS AND RETAINED CARTRIDGES WERE TESTED AND ARE FUNCTIONING ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT RESULT ON A (B)(6) MALE PATIENT PRESENTED TO THE ED COMPLAINING OF CHEST PAIN. THE PATIENT HAS NO MEDICAL HISTORY, AND TAKES NO MEDICATIONS. PATIENT DOES SMOKE AND HAS A HISTORY OF CRYSTAL METH. USE. PATIENT WAS ADMITTED FOR OBSERVATION. TEST DATE: (B)(6) 2013; (B)(6). NO LAB TEST PERFORMED AND BOTH I-STAT TESTS WERE RUN WITH THE SAME PATIENT SAMPLE. THERE WAS NO OTHER PATIENT INFORMATION RECEIVED AT THIS TIME. 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
    107578 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE NA U12283

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR