BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACTK (KAOLIN) CARTRIDGE

    MDR report key: 2130290 · Received May 9, 2011

    Report

    Report Number
    2245578-2011-00064
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 20, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ABBOTT POINT OF CARE CANADA LTD.,
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED A DELAY IN OBTAINING RESULTS WITH AN I-STAT ACT KAOLIN CARTRIDGE WITH A PATIENT IN THE CATH LAB. THE CARTRIDGE WAS RUNNING AND THE ANALYZER TIMED OUT AFTER 15 MINUTES. THE TEST WAS REPEATED AND A RESULT WAS OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT ACTK (KAOLIN) CARTRIDGE ACTK CARTRIDGE JJE ABBOTT POINT OF CARE CANADA LTD., NA S11003B

    Patients

    Seq Age Sex Outcome Treatment
    1