BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-STAT EG6+ CARTRIDGE

    MDR report key: 1924963 · Received November 22, 2010

    Report

    Report Number
    2245578-2010-00151
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    August 26, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ABBOTT POINT OF CARE CANADA LTD.
    Product Code
    JJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, ABBOTT POINT OF CARE WAS CONTACTED BY A CUSTOMER WHO REPORTED THE EG6+ CARTRIDGE THAT HAD ONE CARTRIDGE THAT LEAKED THE BLOOD SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 I-STAT EG6+ CARTRIDGE EG6+ CARTRIDGE JJE ABBOTT POINT OF CARE CANADA LTD. P10069

    Patients

    Seq Age Sex Outcome Treatment
    1 Other