BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3940998 · Received April 24, 2014

    Report

    Report Number
    3004464228-2014-00537
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 28, 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 REPORTED BENT CANNULA OR TO DETERMINE WHETHER IT CONTRIBUTED TO THE HYPERGLYCEMIA. THE USER REPORTED A DISLODGE CANNULA. THIS CONDITION WOULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA IF IT OCCURED. QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ON (B)(6) 2014 HER BLOOD GLUCOSE, CARBOHYDRATE INTAKE AND INSULIN HISTORY. THE POD WAS DEACTIVATED AT 8:46 AM, SHE THEN REALIZED THE CANNULA WAS SLIGHTLY BENT AND IT WAS NO LONGER INSERTED INTO THE INFUSION SITE. SHE WAS ABLE TO ACTIVATE A NEW POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248173 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L40618

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR