BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CARTRIDGE

    MDR report key: 892568 · Received August 10, 2007

    Report

    Report Number
    2245578-2007-00023
    Event Type
    Malfunction
    Date Received
    August 10, 2007
    Date of Event
    July 6, 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

    IN 2007, ABBOTT POINT OF CARE WAS NOTIFIED THAT A CUSTOMER REPORTED A HEMATOCRIT RESULT DISCREPANCY THAT OCCURRED ON ELEVEN DAYS EARLIER. THE CUSTOMER WAS UNABLE TO IDENTIFY WHICH CARTRIDGE TYPE OR CARTRIDGE LOT WAS USED. A HEMATOCRIT RESULT OF 22% PCV WAS OBTAINED FROM THE I-STAT SYSTEM. SINCE THIS RESULT WAS CONSIDERED TO BE NOT COMPATIBLE WITH THE PATIENT'S CLINICAL SITUATION, ANOTHER SAMPLE WAS COLLECTED AND RUN ON A DIFFERENT SYSTEM. THE REPEAT HEMATOCRIT RESULTS WAS 35% PCV. NO TREATMENT WAS ADMINISTERED BASED ON THE I-STAT HEMATOCRIT RESULT OF 22% PCV.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR