BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EC8+ CARTRIDGE

    MDR report key: 2012295 · Received March 4, 2011

    Report

    Report Number
    2245578-2011-00032
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 4, 2011
    Manufacturer
    ABBOTT POINT OF CARE CANADA LTD.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 THAT AN I-STAT EC8+ CARTRIDGE YIELDED STAROUTS (*** OUTS) FOR PH AND PCO2 AT AN 80% FAILURE RATE. THERE WERE NO INJURIES REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT EC8+ CARTRIDGE EC8+ CARTRIDGE JJE ABBOTT POINT OF CARE CANADA LTD. NA H10322

    Patients

    Seq Age Sex Outcome Treatment
    1