BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2133788 · Received May 12, 2011

    Report

    Report Number
    3004464228-2011-00207
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    February 20, 2011
    Report Date
    April 15, 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. RESIDUAL FLUID AND CORROSION WERE FOUND ON THE SURFACES OF INTERNAL ASSEMBLIES, 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 EVIDENCE OF THIS FAILURE MODE. ULTIMATELY, 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). THE OCCURRENCE RATE OF THIS FAILURE MODE IS PROJECTED TO BE 0.318/10,000 FOR THIS LOT; IMPROVEMENT ACTIVITIES ARE IN-PROCESS. 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 REPORT INDICATED THAT THE CUSTOMER EXPERIENCED CONSISTENTLY HIGH BG LEVELS DESPITE HAVING ADMINISTERED MULTIPLE CORRECTION BOLUSES. OVER A FIVE HOUR PERIOD, BG LEVELS RANGED FROM 391-498 MG/DL. NO SPECIFIC FAILURE MODE WAS REPORTED. THE POD WAS DEACTIVATED AND 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 L30441

    Patients

    Seq Age Sex Outcome Treatment
    1 Other