BEUDAMED
    FDA Adverse Event Other Summary report: N

    I-STAT EG7+ CARTRIDGE

    MDR report key: 1345040 · Received March 5, 2009

    Report

    Report Number
    2245578-2009-00005
    Event Type
    Other
    Date Received
    March 5, 2009
    Date of Event
    February 16, 2009
    Report Date
    March 5, 2009
    Manufacturer
    ABBOTT POINT OF CARE CANADA LTD.
    Product Code
    GKF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B) (6) 2009, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED AN I-STAT EG7+ CARTRIDGE FIELDED A HEMATOCRIT RESULT OF 19%. THE SAME SAMPLE TESTED USING A LABORATORY SYSTEM YIELDED A HEMATOCRIT RESULT OF 23%. THE PT WAS GIVEN A TRANSFUSION (PACKED RED BLOOD CELLS) BASED ON THE I-STAT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT EG7+ CARTRIDGE EG7+ CARTRIDGE GKF ABBOTT POINT OF CARE CANADA LTD. NA P08326A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other