BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT PT/INR CARTRIDGES

    MDR report key: 2505742 · Received March 20, 2012

    Report

    Report Number
    2245578-2012-00168
    Event Type
    Malfunction
    Date Received
    March 20, 2012
    Date of Event
    March 19, 2012
    Report Date
    March 19, 2012
    Manufacturer
    ABBOTT POINT OF CARE, INC.
    Product Code
    GJS
    PMA / PMN Number
    K020355
    Removal / Correction Number
    APOC2012-003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DETAILS WILL BE PROVIDED WITH THE ACTION THAT WILL BE CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION. (B)(4).

    Description of Event or Problem · 1

    A REMEDIAL ACTION HAS BEEN INITIATED TO PROVIDE RECOMMENDATIONS TO THE CUSTOMER FOR PRODUCT IN THE FIELD. ABBOTT POINT OF CARE INC. (APOC) HAS DETERMINED THAT STAT PT/INR CARTRIDGES HAVE THE POTENTIAL TO EXHIBIT INCORRECTLY ELEVATED RESULTS. INTERNAL STUDIES HAVE DEMONSTRATED THAT I-STAT PT/INR RESULTS ARE ELEVATED BY AN AVERAGE OF APPROXIMATELY 20% IN THE THERAPEUTIC RANGE OF 1.8 TO 3.5 INR. THIS ACTION IS BEING CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION AND HEALTH (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT PT/INR CARTRIDGES PT/INR CARTRIDGES GJS ABBOTT POINT OF CARE, INC. NA ALL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA