BEUDAMED
    FDA Adverse Event Other Summary report: N

    I-STAT CHEM 8+ CARTRIDGE

    MDR report key: 1421676 · Received July 10, 2009

    Report

    Report Number
    2245578-2009-00018
    Event Type
    Other
    Date Received
    July 10, 2009
    Date of Event
    June 12, 2009
    Report Date
    July 10, 2009
    Manufacturer
    ABBOTT POINT OF CARE CANADA LTD.
    Product Code
    GKF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2009, ABBOTT POINT OF ACRE WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT AN I-STAT CHEM 8+ CARTRIDGE YIELDED A HEMATOCRIT RESULT OF 28% PCV. THE SAMPLE (UNK IF THE SAME SAMPLE) USING A LABORATORY SYSTEM YIELDED A HEMATOCRIT RESULT OF 23% PCV. THERE WAS A DELAY (TIME FRAME UNK) ON THE TRANSFUSION TO THE PATIENT. THERE IS NOT INDICATION OF THE I-STAT CHEM 8+ CARTRIDGE MALFUNCTIONING. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CHEM 8+ CARTRIDGE CHEM 8+ CARTRIDGE GKF ABBOTT POINT OF CARE CANADA LTD. P09063A

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other