BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 2559925 · Received April 20, 2012

    Report

    Report Number
    2245578-2012-00321
    Event Type
    Malfunction
    Date Received
    April 20, 2012
    Date of Event
    January 25, 2012
    Report Date
    April 13, 2012
    Manufacturer
    ABBOTT POINT OF CARE, INC.
    Product Code
    MMI
    PMA / PMN Number
    K031739
    Removal / Correction Number
    APOC-2012-002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(4) 2012, THE INCIDENT WAS IDENTIFIED AND LINKED TO AN INVESTIGATION THAT WAS COMPLETED ON (B)(4) 2012 AND A DEFICIENCY WAS IDENTIFIED. (B)(4). DETAILS WERE PROVIDED WITH THE ACTION THAT WAS CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION.

    Description of Event or Problem · 1

    ON (B)(6) 2012, ABBOTT POINT OF CARE WAS CONTACTED BY AN ABBOTT DISTRIBUTOR IN THE VETERINARY MARKET WHO'S CUSTOMER COMPLAINT IS THAT I-STAT TROPONIN CARTRIDGES ARE YIELDING A HIGHER THAN NORMAL RATE OF QUALITY CHECK CODE (QCC) 69, QCC 133 AND QCC 145. THE CUSTOMER STATES THAT 3 OF 10 FAILED. BASED ON THE INFO 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, INC. NA U11246

    Patients

    Seq Age Sex Outcome Treatment
    1 NA