BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT TROPONIN (CTNI)

    MDR report key: 2130287 · Received May 9, 2011

    Report

    Report Number
    2245578-2011-00066
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    March 21, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ABBOTT POINT OF CARE CANADA LTD.
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER RETURNED CARTRIDGES WERE VISUALLY INSPECTED AND CONFIRMED CUSTOMER COMPLAINT. TAPE GASKET HOLE CUT FOR THE SAMPLE ENTRY WELL WAS NOT PRESENT WHICH PREVENTED SAMPLE FROM ENTERING THE CARTRIDGE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT I-STAT TROPONIN CARTRIDGES WERE DIFFICULT TO FILL DUE TO A PLASTIC PIECE COVERING THE SAMPLE WELL. BASED ON THE INFORMATION AT THE TIME, THERE WAS NO INJURY ASSOCIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT TROPONIN (CTNI) CTNI CARTRIDGE MMI ABBOTT POINT OF CARE CANADA LTD. T11016A

    Patients

    Seq Age Sex Outcome Treatment
    1