BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3850349 · Received March 18, 2014

    Report

    Report Number
    3004464228-2014-00342
    Event Type
    Malfunction
    Date Received
    March 18, 2014
    Date of Event
    January 22, 2014
    Report Date
    February 19, 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 PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE KINKED CANNULA OR TO DETERMINE WHETHER IT CONTRIBUTED TO THE HYPERGLYCEMIA. THE USER ALSO REPORTED A DISLODGED CANNULA. THIS CONDITION WOULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA IF IT OCCURRED. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HER BLOOD GLUCOSE REACHED 392 MG/DL LESS THAN 24 HRS AFTER THE POD WAS ACTIVATED. THE ADHESIVE PAD WAS WET AND SHE DECIDED TO REMOVE THE POD. SHE STATED THE CANNULA WAS KINKED AND IT WAS NO LONGER INSERTED INTO THE INFUSION SITE. THE POD WAS THEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160485 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40807

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR