BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CG8+ CARTRIDGE

    MDR report key: 770384 · Received August 18, 2006

    Report

    Report Number
    2245578-2006-00017
    Event Type
    Malfunction
    Date Received
    August 18, 2006
    Date of Event
    July 21, 2006
    Report Date
    August 18, 2006
    Manufacturer
    I-STAT CORP
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ABBOTT POINT OF CARE WAS CONTACTED IN 2006, BY A CUSTOMER WHO STATED THAT FOR ONE PARTICULAR PT, A PERFUSIONIST QUESTIONED THE HEMATOCRIT RESULTS THAT WERE RESULTED FROM THE I STAT SYSTEM. @ 9:20 AM, THE HEMATOCRIT RESULT WAS 20 %PCV. @ 9:47 AM, THE HEMATOCRIT RESULT WAS 34 %PCV, AND @ 10:19, AM THE HEMATOCRIT RESULT WAS 74 %PCV. IT IS NOT KNOW IF THE PT WAS RECEIVING BLOOD PRODUCTS DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CG8+ CARTRIDGE IVD MMI I-STAT CORP NA L06120

    Patients

    Seq Age Sex Outcome Treatment
    1 *