BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CG8+ CARTRIDGE

    MDR report key: 892567 · Received August 12, 2007

    Report

    Report Number
    2245578-2007-00024
    Event Type
    Malfunction
    Date Received
    August 12, 2007
    Date of Event
    July 19, 2007
    Report Date
    August 10, 2007
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JJE
    PMA / PMN Number
    K894914A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON JULY 24, 2007, ABBOTT POINT OF CARE WAS NOTIFIED THAT A CUSTOMER REPORTED A HEMATOCRIT RESULT DISCREPANCY THAT OCCURRED ON FIVE DAYS EARLIER. THE CUSTOMER WAS UNABLE TO IDENTIFY WHICH CARTRIDGE LOT WAS IN USE. A HEMATOCRIT RESULT OF 22% PCV WAS OBTAINED FROM THE I-STAT SYSTEM. TEN MINUTES LATER, ANOTHER SAMPLE WAS TESTED ON THIS PATIENT AND THE HEMATOCRIT RESULT WAS 25% PCV. SINCE THESE RESULTS WERE CONSIDERED TO BE NOT COMPATIBLE WITH THE PATIENT'S CLINICAL SITUATION. BOTH SAMPLES WERE RETESTED ON A DIFFERENT SYSTEM. THE REPEAT HEMATOCRIT RESULTS WERE 36% PCV FOR BOTH SAMPLES. NO TREATMENT WAS ADMINISTERED BASED ON THE I-STAT HEMATOCRIT RESULT OF 22% PCV. THE PATIENT WAS TAKEN TO SURGERY BASED ON THE RESULT FROM THE DIFFERENT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CG8+ CARTRIDGE IVD JJE ABBOTT POINT OF CARE INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR