BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CTNI CARTRIDGE

    MDR report key: 1082942 · Received July 28, 2008

    Report

    Report Number
    2245578-2008-00049
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 21, 2008
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS PRODUCT MEETS THE CRITERIA FOR A 5-DAY MDR AS DESCRIBED IN THE FDA'S NOTICE DATED APRIL 8 2008 [TO MFRS AND INITIAL DISTRIBUTORS OF MEDICAL DEVICES THAT MAY CONTAIN HEPARIN OR ARE HEPARIN-COATED], AND ABBOTT IS SUBMITTING THIS 5-DAY MDR. OUR INVESTIGATION INTO THIS EVENT IS ONGOING AND A SUPPLEMENTAL MDR WILL BE SUBMITTED AT THE CONCLUSION OF OUR INVESTIGATION. ON 07/16/2008, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED AT 21:44 AN I-STAT CARDIAC TROPONIN I CARTRIDGE YIELDED A RESULT OF 1.16 NG/ML. SAME SAMPLE RUN ON A DIFFERENT I-STAT 1 ANALYZER AT 22:14 USING AN I-STAT CARDIAC TROPONIN I CARTRIDGE YIELDED A RESULT OF 0.00 NG/ML. NEW SAMPLE COLLECTED, SENT TO THE LABORATORY AT 812:01 YIELDED A RESULT OF <0.02 NG/ML. BD LITHIUM HEPARIN TUBE USED, LOT NUMBER UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CTNI CARTRIDGE IVD MMI ABBOTT POINT OF CARE INC. NA T08104A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR