BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EG7+ CARTRIDGE

    MDR report key: 862852 · Received September 26, 2006

    Report

    Report Number
    2245578-2006-00020
    Event Type
    Malfunction
    Date Received
    September 26, 2006
    Report Date
    September 26, 2006
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON AUGUST 31, 2006, 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 EG7+ CARTRIDGES LOT #U06034 RUN ON I-STAT ANALYZER PRODUCED A HEMATOCIRT RESULT OF 30% PCV. THE SAME SAMPLE WAS TESTED ON ANOTHER I-STAT ANALYZER USING THE SAME LOT NUMBER OF EG7+ CARTRIDGES AND PRODUCED A HEMATOCRIT RESULT WAS 25% PCV. THE CUSTOMER REPORTED THAT THE SAME BLOOD SAMPLE WAS TESTED ON A BAYER RAPID POINT 405 ANALYZER AND PRODUCED A HEMATOCRIT RESULT OF 26% PCV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT EG7+ CARTRIDGE IVD MMI ABBOTT POINT OF CARE INC. NA U06034

    Patients

    Seq Age Sex Outcome Treatment
    1 *