BEUDAMED
    FDA Adverse Event Other Summary report: N

    I-STAT KAOLIN ACT CARTRIDGE

    MDR report key: 1641238 · Received March 16, 2010

    Report

    Report Number
    2245578-2010-00013
    Event Type
    Other
    Date Received
    March 16, 2010
    Date of Event
    February 12, 2010
    Report Date
    March 16, 2010
    Manufacturer
    ABBOTT POINT OF CARE CANADA LTD.
    Product Code
    JBP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 KAOLIN ACT CARTRIDGE YIELDED 192 SECONDS ON (B)(6) 2010 AT 03:24 AND A 192 SECONDS ON (B)(6) 2010 AT 03:52. THE I-STAT ACT K RESULTS CAUSED A 12 HOUR DELAY IN THE REMOVAL OF A SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT KAOLIN ACT CARTRIDGE ACT K CARTRIDGE JBP ABBOTT POINT OF CARE CANADA LTD. R09320D

    Patients

    Seq Age Sex Outcome Treatment
    1 Other