BEUDAMED
    FDA Adverse Event Death Summary report: N

    I-STAT ACT CELITE CARTRIDGE

    MDR report key: 2600817 · Received June 1, 2012

    Report

    Report Number
    2245578-2012-00355
    Event Type
    Death
    Date Received
    June 1, 2012
    Date of Event
    May 10, 2012
    Report Date
    May 10, 2012
    Manufacturer
    ABBOTT POINT OF CARE INC.
    Product Code
    JBP
    PMA / PMN Number
    K992571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ON (B)(6) 2012, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER REGARDING ACT CELITE CARTRIDGES THAT YIELDED DISCREPANT RESULTS. THE CUSTOMER STATES THAT PATIENT CAME TO CATH LAB, PROCEDURE WAS COMPLETED, PATIENT WAS SENT TO ICU THEN EXPIRED. THE CUSTOMER DID NOT HAVE TIME SAMPLE WAS TESTED, RESULTS OR HEPARIN DOSE. ABBOTT POINT OF CARE BELIEVES THAT THOUGH A MALFUNCTION DOES NOT EXIST AT THIS TIME. HOWEVER, THE CUSTOMER STATED WHEN ASKED BY AN ABBOTT POINT OF CARE TECHNICAL SUPPORT SPECIALIST THAT THE DOCTOR BELIEVED THE ACT RESULTS WERE RELATED TO THE DEATH. THERE IS NO FURTHER PATIENT INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT ACT CELITE CARTRIDGE ACT CELITE CARTRIDGE JBP ABBOTT POINT OF CARE INC. NA S11348

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention