BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI POD INSULIN PUMP

    MDR report key: 4003043 · Received June 25, 2014

    Report

    Report Number
    3004464228-2014-00870
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 27, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. WE ARE UNABLE TO CONFIRM THE KINKED CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. THE CUSTOMER ALSO REPORTED THAT THE CANNULA MAY HAVE DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT QUALIFICATIONS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTED CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER BLOOD GLUCOSE ROSE TO 320 MG/DL. SHE ALSO REPORTED THAT THE CANNULA MAY NOT BE INSERTED PROPERLY AND MAY BE KINKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369771 OMNI POD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14810-5E L40889

    Patients

    Seq Age Sex Outcome Treatment
    1