BEUDAMED
    FDA Adverse Event Other Summary report: N

    I-STAT ACT K CARTRIDGE

    MDR report key: 1221629 · Received October 24, 2008

    Report

    Report Number
    2245578-2008-00076
    Event Type
    Other
    Date Received
    October 24, 2008
    Date of Event
    September 24, 2008
    Report Date
    October 24, 2008
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JBP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON 09/24/2008, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED AN I-STAT ACT K CARTRIDGE YIELDED THREE SEPARATE SAMPLE RESULTS OF 140 SECONDS IN 2008 AT 6:57PM, 8:25PM AND 9:51PM WHICH MAY HAVE CONTRIBUTED TO THE DELAY IN PULLING THE SHEATH BY 7.5 HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT ACT K CARTRIDGE IVD JBP ABBOTT POINT OF CARE INC. NA R08141

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR