BEUDAMED
    FDA Adverse Event Other Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 813613 · Received February 1, 2007

    Report

    Report Number
    2245578-2007-00002
    Event Type
    Other
    Date Received
    February 1, 2007
    Date of Event
    December 31, 2006
    Report Date
    February 1, 2007
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER IN 2007, THAT A PATIENT SAMPLE GENERATED AN I-STAT HEMATOCRIT RESULT OF 21% PCV AND THE LABORATORY RESULT WAS 34% PCV. THE PT WAS GIVEN 2 UNITS OF PACKED RED BLOOD CELLS BASED ON THE HEMATOCRIT RESULT, THE I-STAT CHEM 8+ LOT P06270.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CHEM8+ CARTRIDGE IVD MMI ABBOTT POINT OF CARE INC. NA P06270

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other