BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM 8+N CARTRIDGE

    MDR report key: 1893966 · Received November 3, 2010

    Report

    Report Number
    2245578-2010-00141
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 11, 2010
    Report Date
    November 3, 2010
    Manufacturer
    ABBOTT POINT OF CARE CANADA LTD
    Product Code
    GKF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THE I-STAT CHEM 8+ CARTRIDGE YIELDED A HEMATOCRIT RESULT OF 37% PCV. A SEPARATE SAMPLE, DRAWN AT THE SAME TIME AS THE I-STAT SAMPLE, WAS TESTED ON THE LAB INSTRUMENT AND THE HEMATOCRIT RESULT WAS 15.4% PCV. NO REPEAT LABS PERFORMED. PATIENT WAS NOT TREATED ON EITHER HEMATOCRIT RESULT. PATIENT DIED OF RESPIRATORY FAILURE AT 6:30PM (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CHEM 8+N CARTRIDGE CHEM 8+ CARTRIDGE GKF ABBOTT POINT OF CARE CANADA LTD G10170

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR