BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2140857 · Received May 31, 2011

    Report

    Report Number
    3004464228-2011-00239
    Event Type
    Malfunction
    Date Received
    May 31, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 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 INVESTIGATION OF THE RETURNED POD FOUND DISCOLORATION INSIDE THE DEVICE, WHICH IS EVIDENCE OF AN INTERNAL FLUID LEAK. A LEAK TEST WAS PERFORMED, WHICH CONFIRMED THE PRESENCE OF A LEAK IN THE FLUID PATH CAUSED BY A TEAR IN THE CANNULA TUBING. THE LEAK WOULD HAVE RESULTED IN INSULIN COMING INTO CONTACT WITH INTERNAL COMPONENTS AND ASSEMBLIES, ULTIMATELY CAUSING THE DEVICE TO FAIL. A POD MALFUNCTION, THEREFORE, IS CONFIRMED TO HAVE BEEN A CONTRIBUTING FACTOR TO THE CUSTOMER'S HIGH BG LEVELS. A REVIEW OF LOT QUALIFICATION RECORDS REVEALED NO EVIDENCE OF THIS FAILURE MODE. LOT QUALIFICATION RESULTS WERE DEEMED ACCEPTABLE AND THE LOT PASSED THE ACCEPTANCE CRITERIA. INSULET HAS INITIATED AN INTERNAL INVESTIGATION INTO THIS PARTICULAR FAILURE MODE AND HAS TAKEN MULTIPLE ACTIONS TO MINIMIZE AND PREVENT ITS RECURRENCE. A RISK ASSESSMENT HAS ALSO BEEN CONDUCTED AS WELL AS ONGOING MONITORING TO ENSURE THAT THIS LEVEL OF FAILURE DOES NOT EXCEED ACTION LIMITS (AS DEFINED BY INSULET'S INTERNAL PROCEDURES). LABELING, TRAINING AND CLINICAL ADVICE CONTINUES TO INDICATE THAT ONGOING BG MONITORING IS NECESSARY. ALTHOUGH, WE DO NOT RELY ON LABELING, THIS IS ADDITIONAL MITIGATION AS PART OF THE NORMAL ACTIVITIES OF A DIABETIC.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT SHE FELT THE POD "HAD FAILED ON HER." THE DEVICE WAS APPLIED IN THE EVENING AND, BY EARLY MORNING, HER BG LEVELS HAD SIGNIFICANTLY INCREASED (FROM 104 TO 295MG/DL). A CORRECTION BOLUS WAS ADMINISTERED, BUT AN HOUR LATER, HER LEVELS CONTINUED TO RISE (UP TO 348MG/DL). THE POD WAS IMMEDIATELY DEACTIVATED AND WILL BE RETURNED FOR EVALUATION. NO SPECIFIC DEVICE FAILURE MODE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30467

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other