BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 2821471 · Received November 6, 2012

    Report

    Report Number
    2245578-2012-00397
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    MMI
    PMA / PMN Number
    K031739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012, ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT RESULT ON A PATIENT PRESENTED WITH CHEST PAIN. RESULT TIME COLLECTION TIME (B)(6) 13:050.09 13:12, SAMPLE 1 0.00 13:31, REPEAT ON SAME SAMPLE0.01 13:49, REPEAT ON SAME SAMPLETHERE WAS NO LAB COMPARISON PERFORMED. THE CUSTOMER STATES THAT THE PATIENT'S FINAL DIAGNOSIS WAS THAT THE PATIENT WAS OVER WORKED DAYS AFTER GAUL BLADDER SURGERY - DISCHARGEDBASED 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 NA P12163A

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR