BEUDAMED
    FDA Adverse Event Other Summary report: N

    I-STAT CELITE ACT CARTRIDGE

    MDR report key: 1748840 · Received June 21, 2010

    Report

    Report Number
    2245578-2010-00035
    Event Type
    Other
    Date Received
    June 21, 2010
    Date of Event
    April 1, 2010
    Report Date
    June 21, 2010
    Manufacturer
    ABBOTT POINT OF CARE CANADA, LTD.
    Product Code
    JBP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THE I-STAT CELITE ACT CARTRIDGE YIELDED 158 SECONDS. THE I-STAT ACT C RESULTS CAUSED DELAY IN THE REMOVAL OF A SHEATH, EXACT TIME FRAME IS NOT KNOWN. THE CUSTOMER STATED IT WAS DELAYED TO THE NEXT DAY, THEY FELT THE SHEATH COULD HAVE BEEN PULLED THE NIGHT BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT CELITE ACT CARTRIDGE ACT C CARTRIDGE JBP ABBOTT POINT OF CARE CANADA, LTD. R09329C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other