BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3932299 · Received April 4, 2014

    Report

    Report Number
    3004464228-2014-00445
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 8, 2014
    Report Date
    March 8, 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 BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. THE CUSTOMER ALSO REPORTED THAT THE CANNULA WAS NOT PROPERLY INSERTED AT THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTED CRITERIA.

    Description of Event or Problem · 1

    A RELATIVE OF THE CUSTOMER CALLED TO REPORT THAT THE CUSTOMER HAD HIGH (>500 MG/DL) BLOOD GLUCOSE LEVELS, AND THAT IT WAS NOTICED THAT THE CANNULA HAS DISLODGED FROM THE INSERTION SITE, INSULIN WAS LEAKING ONTO THE ADHESIVE, AND THE CANNULA WAS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205477 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40811

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR