BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 2313389 · Received October 3, 2011

    Report

    Report Number
    2245578-2011-00224
    Event Type
    Malfunction
    Date Received
    October 3, 2011
    Date of Event
    September 23, 2011
    Report Date
    September 23, 2011
    Manufacturer
    ABBOTT POINT OF CARE CANADA LTD.
    Product Code
    MMI
    Removal / Correction Number
    APOC2011-007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A REMEDIAL ACTION HAS BEEN INITIATED TO NOTIFY THE CUSTOMER AND REMOVE AFFECTED PRODUCT FROM THE FIELD. ABBOTT POINT OF CARE INC (APOC) HAS DETERMINED THAT LOTS OF I-STAT CTNI CARTRIDGES BEGINNING WITH LETTER "T" MAY EXHIBIT A HIGHER THAN EXPECTED VARIABILITY IN REPORTED RESULTS. ALL OTHER CTNI LOTS ARE UNAFFECTED BY THIS ISSUE. THIS INCREASED VARIABILITY MAY RESULT IN FALSELY ELEVATED OR FALSELY DEPRESSED RESULTS. THIS ACTION IS BEING CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION AND HEALTH (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT TROPONIN (CTNI) CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE CANADA LTD. NA MULTIPLE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA