BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT ACTC (CELITE)

    MDR report key: 2100103 · Received May 16, 2011

    Report

    Report Number
    2245578-2011-00070
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 13, 2011
    Manufacturer
    ABBOTT POINT OF CARE CANADA LTD.
    Product Code
    JBP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 I-STAT ACT-CELITE CARTRIDGES WERE PRODUCING ERROR CODE 31. THE CUSTOMER OBTAINED 31 OF THESE ERROR CODES BETWEEN (B)(6) 2011 AND 04/18/2011. BASED ON THE INFORMATION AVAILABLE THERE WERE NO INJURIES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT ACTC (CELITE) ACTC CARTRIDGE JBP ABBOTT POINT OF CARE CANADA LTD. NA S11045A

    Patients

    Seq Age Sex Outcome Treatment
    1