BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT CHEM8+ CARTRIDGE

    MDR report key: 959688 · Received December 6, 2007

    Report

    Report Number
    2245578-2007-00117
    Event Type
    Malfunction
    Date Received
    December 6, 2007
    Date of Event
    November 7, 2007
    Report Date
    December 6, 2007
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IN 2007, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THAT ON THE SAME DAY, AN I-STAT CHEM8+ CARTRIDGE YIELDED A HEMATOCRIT RESULT OF 25% PCV. A SAMPLE WAS TESTED THE SAME DAY, USING LAB INSTRUMENT YIELDED A RESULT OF 29% PCV. NO TREATMENT WAS ADMINISTERED BASED ON THE I-STAT HEMATOCRIT RESULT OF 25% PCV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CHEM8+ CARTRIDGE IVD JJE ABBOTT POINT OF CARE INC. NA L07122

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR