BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2113388 · Received May 25, 2011

    Report

    Report Number
    3004464228-2011-00232
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 29, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POD WAS RETURNED WITH THE NEEDLE MECHANISM UN-DEPLOYED. IT WAS DETERMINED THAT THE NEEDLE MECHANISM HAD NOT FIRED DUE TO INTERFERENCE FROM A DAMAGED COMPONENT. SINCE THE NEEDLE MECHANISM FAILED TO FIRE, THE CANNULA WOULD NOT HAVE INSERTED SUBCUTANEOUSLY INTO THE CUSTOMER, WHICH WOULD HAVE LEAD TO HIGH BG LEVELS AS REPORTED. THE USER FAILED TO NOTE THIS CONDITION UPON PLACING THE POD. BY CHECKING THE VIEWING WINDOW, IT WOULD HAVE BEEN OBSERVED THAT THE CANNULA HAD NOT FIRED AND THE POD WOULD NOT HAVE BEEN WORN. THE OMNIPOD USER'S GUIDE INSTRUCTS THE USER TO "CHECK THE INFUSION SITE AFTER INSERTION TO ENSURE THAT THE CANNULA WAS PROPERLY INSERTED. IT IS ALSO A GOOD IDEA TO CHECK YOUR BLOOD GLUCOSE ABOUT TWO HOURS AFTER EACH POD CHANGE AND TO CHECK THE INFUSION SITE PERIODICALLY. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT." LOT QUALIFICATION RECORDS WERE REVIEWED AND NO ISSUES RELATED TO A FAILURE OF THE NEEDLE MECHANISM TO DEPLOY WERE FOUND. THE LOT PASSED THE ACCEPTANCE CRITERIA. INSULET HAS INITIATED AN INTERNAL INVESTIGATION INTO THIS PARTICULAR FAILURE MODE AND HAS TAKEN ACTIONS TO MINIMIZE AND PREVENT ITS RECURRENCE. IMPROVEMENTS ARE IN-PROCESS AS OF THE FILING OF THIS SUBMISSION.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THERE "WAS A LOT OF DISTRACTION" AT THE TIME HE WAS ACTIVATING THE POD AND, AS A RESULT, HE "DID NOT RECALL FEELING CANNULA INSERTION." IN ADDITION, NEITHER HE NOR HIS SPOUSE "WERE ABLE TO SEE IF THE CANNULA HAD BEEN INSERTED." A COUPLE HOURS AFTER PLACING THE POD, HIS BG LEVELS SPIKED TO 400MG/DL. THE POD WAS REMOVED AND IT WAS OBSERVED THAT THE ADHESIVE PAD WAS WET AND SMELLED OF INSULIN AND THE "CANNULA HAD NEVER DEPLOYED." THE POD WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30453

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other