BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CTNI CARTRIDGE

    MDR report key: 1928451 · Received November 24, 2010

    Report

    Report Number
    2245578-2010-00154
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    July 19, 2010
    Report Date
    November 24, 2010
    Manufacturer
    ABBOTT POINT OF CARE CANADA LTD
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APOC CONDUCTED AND INTERNAL REVIEW OF QUALITY DATA AND CUSTOMER-RETURNED PRODUCT TESTING INDICATE THAT A SECTION OF CTNI LOT S10130A IS ASSOCIATED WITH ELEVATED RATES OF QCC 149. QUALITY ACCEPTANCE CRITERIA IS BEING EVALUATED/UPDATED TO ENSURE APOC INSPECTION CAPTURES ELEVATES QCC RATES.

    Description of Event or Problem · 1

    ABBOTT POINT OF CARE (APOC) WAS CONTACTED BY THE CUSTOMER STATING THE I-STAT CTNI CARTRIDGES WERE YIELDING AN INCREASE IN THE NUMBER OF QUALITY CHECK CODE (QCC) 149. BASED ON THE INFO PROVIDED BY THE CUSTOMER, THERE WAS NO INDICATION OF PT IMPACT DUE TO INCREASE IN QCC 149S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CTNI CARTRIDGE CTNI CARTRIDGE MMI ABBOTT POINT OF CARE CANADA LTD S10130A

    Patients

    Seq Age Sex Outcome Treatment
    1