BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACTK (KAOLIN) CARTRIDGE

    MDR report key: 2192522 · Received June 30, 2011

    Report

    Report Number
    2245578-2011-00106
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 30, 2011
    Manufacturer
    ABBOTT POINT OF CARE CANADA, LTD.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING I-STAT ACT CELITE WHERE A PTS RESULTS WAS YIELDING >1000 SECONDS IN THE CVOR WHERE THERAPEUTIC RANGE IS AROUND 350 SECONDS. RECHECKED RESULTS ON ANOTHER ANALYZER AND THE RESULT WAS >1000 SECONDS. WHEN REPEATED ON ANOTHER LOT THE RESULT OBTAINED WAS 350 SECONDS. BASED ON THE INFO AVAILABLE AT THE TIME, THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT. PT MEDICATIONS: DRONEDAONE, DILTIAZEM HCL, OMEPRAZOLE, WARFARIN NA, 7.5 MG, POTASSIUM CHLORIDE, TRIAMTERENE-HYDROCHLOROTHIAZIDE, FISH OIL OMEGA-3 FATTY ACIDS, CALCIUM CARBONATE/VIT B3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT ACTK (KAOLIN) CARTRIDGE ACTK CARTRIDGE JJE ABBOTT POINT OF CARE CANADA, LTD. NA S11090C

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR