BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT ISTAT

    MDR report key: 24873627 · Received April 14, 2026

    Report

    Report Number
    MW5186805
    Event Type
    Other
    Date Received
    April 14, 2026
    Report Date
    April 9, 2026
    Manufacturer
    ABBOTT POINT OF CARE CANADA LIMITED
    Product Code
    JJY
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS NOTED THAT DURING CARDIAC CATHETERIZATION, ONCE THE PATIENT WAS DOSED WITH HEPARIN THE ISTAT ACT-K CARTRIDGE WAS NOT SHOWING A CHANGE IN RESULTS BASED ON THE DOSING. WE ARE CURRENTLY SWITCHING OVER TO THE HEPCON INSTRUMENT UNTIL WE CAN BRING IN THE ISTAT ACT-C CARTRIDGE. WE HAD A DISCUSSION WITH ABBOTT YESTERDAY AND THEY HAD ALREADY HAD REPORTS OF THIS SAME ISSUE AND AN INVESTIGATION WAS INITIATED. CURRENTLY THERE HAS BEEN NO HARM TO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929186 ABBOTT ISTAT MULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED) JJY ABBOTT POINT OF CARE CANADA LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown