BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EC8+ CARTRIDGE

    MDR report key: 837270 · Received February 15, 2007

    Report

    Report Number
    2245578-2007-00006
    Event Type
    Malfunction
    Date Received
    February 15, 2007
    Date of Event
    January 22, 2007
    Report Date
    February 15, 2007
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    CEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON JANUARY 23, 2007, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT THEY OBSERVED DISCREPANT HEMATOCRIT RESULTS WHEN A SAMPLE WAS TESTED ON THE I-STAT SYSTEM. I-STAT EC8+ CARTRIDGE LOT A06229 PRODUCED A HEMATOCRIT RESULT OF 30% PCV AT 14:42 IN 2007. A SAMPLE DRAWN AT THE SAME TIME WAS SENT TO THE LABORATORY AND A HEMATOCRIT RESULT OF 22.8 %PCV WAS GENERATED @ 15:37. THE PATIENT SUBSEQUENTLY RECEIVED TWO UNITS OF PACKED RED BLOOD CELLS AND A HEMATOCRIT RESULT OF 26.1 % PCV WAS GENERATED FROM THE LABORATORY ANALYZER @ 2:52.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT EC8+ CARTRIDGE IVD CEM ABBOTT POINT OF CARE INC. NA A06229

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR