BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI) CARTRIDGE

    MDR report key: 2192508 · Received June 30, 2011

    Report

    Report Number
    2245578-2011-00109
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    April 15, 2011
    Report Date
    June 30, 2011
    Manufacturer
    ABBOTT POINT OF CARE CANADA
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION COMPLETED ON (B)(4) 2011, THAT CONCLUDED THE FOLLOWING: RESULTS FROM FINISHED GOODS AND RETURNED CARTRIDGE TESTING INDICATE THAT CTNI LOT (B)(4) CARTRIDGES HAD A SECTION OF 250 CARTRIDGES OUT OF A TOTAL OF 8800 CARTRIDGES WERE FOUND TO BE DEFICIENT WITH RESPECT TO THE RATE QCC 123 RESULTS. THERE WERE NO OTHER DEFICIENCIES OR QUALITY ISSUES IDENTIFIED RELATED TO THE CUSTOMERS COMPLAINT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT TROPONIN CARTRIDGES THAT WERE YIELDING QUALITY CHECK CODES 123, 133, AND 143. BASED ON THE INFO AVAILABLE AT THE TIME, THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT. THE INVESTIGATION WAS COMPLETED ON (B)(4) 2011.

    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 NA T11010

    Patients

    Seq Age Sex Outcome Treatment
    1