BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 4170545 · Received October 14, 2014

    Report

    Report Number
    2245578-2014-00075
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    ABBOTT POINT OF CARE
    Product Code
    MMI
    PMA / PMN Number
    K031739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON 11/10/2014. RETAIN AND RETURNED CARTRIDGES WERE TESTED AND ARE FUNCTIONING ACCORDING TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT YIELDED A SUSPECTED DISCREPANT RESULT OF 0.17 (FALSE POSITIVE) ON A PATIENT. THERE WAS NO PATIENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT. RETURN PRODUCT IS AVAILABLE FOR INVESTIGATION. METHOD:I-STAT, TEST DATE: (B)(6) 2014, DRAW TIME: 12:35, RESULT: 0.00, SAMPLE: A; I-STAT, (B)(6) 2014, 14:51, 0.17, B; I-STAT, (B)(6) 2014, 15:03, 0.00, C; ARCHITECT, (B)(6) 2014, 15:03, 0.02, C; THERE WERE NO INJURIES REPORTED WITH THIS EVENT. THE INVESTIGATION IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651666 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE NA U14176

    Patients

    Seq Age Sex Outcome Treatment
    1