BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 3081135 · Received April 26, 2013

    Report

    Report Number
    2245578-2013-00067
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 11, 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION WAS COMPLETED ON (B)(4) 2013. RETAIN AND RETURNED CARTRIDGES WERE TESTED AND ARE FUNCTIONING ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    NA

    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 PRESENTED IN ER WITH CHEST PAINS/SHORTNESS OF BREATH. TEST DATE: (B)(6) 2013: METHOD: TIME: RESULT: I-STAT, 12:35AM, 0.94 (POSITIVE RESULT). I-STAT, 12:58AM, 0.00 (NEGATIVE RESULT). VISTA, 01:08AM, <0.015 (NEGATIVE RESULT). EKG SHOWED PREMATURE VENTRICULAR COMPLEX. 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
    183069 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE NA U13033A

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR