BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CTNI CARTRIDGE

    MDR report key: 1132663 · Received August 13, 2008

    Report

    Report Number
    2245578-2008-00062
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 13, 2008
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOTT HAS COMPLETED ITS TESTING OF THE HEPARIN LOTS FOR PRODUCTS MEETING THE CRITERIA FOR A 5-DAY MDR AS DESCRIBED IN THE FDA'S NOTICE DATED APRIL 8, 2008 [TO MANUFACTURERS AND INITIAL DISTRIBUTORS OF MEDICAL DEVICES THAT MAY CONTAIN HEPARIN OR ARE HEPARIN-COATED]. THE HEPARIN LOTS IDENTIFIED IN THE APOC MANUFACTURING PROCESS HAVE PASSED THE NUCLEAR MAGNETIC RESONANCE (NMR) AND CAPILLARY ELECTROPHORESIS (CE) TESTS. BECTON DICKINSON (BD) TUBE TESTING WILL COMMENCE PENDING THE APPROVAL, BY FDA, OF THE PROTOCOL.

    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 MANUFACTURERS 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. IN 2008, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED USING AN I-STAT CARDIAC TROPONIN I CARTRIDGE ON WHOLE BLOOD YIELDED A RESULT OF 0.42 NG/ML AND 1.60 NG/ML. SECOND DRAW, TESTED USING AN I-STAT CARDIAC TROPONIN I CARTRIDGE YIELDED A RESULT OF 0.76 NG/ML. UNSURE IF SAME SAMPLES, CUSTOMER STATED "ALL TROPONIN TESTING ON THE PLASMA SAMPLES WERE 0.00."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CTNI CARTRIDGE IVD MMI ABBOTT POINT OF CARE INC. NA T08114

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR