BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2211272 · Received July 12, 2011

    Report

    Report Number
    3004464228-2011-00347
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 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 RESIDUAL FLUID ON THE SURFACES OF INTERNAL ASSEMBLIES AND 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 THE 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 1.3/10,000 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 ADD'L MITIGATION AS PART OF THE NORMAL ACTIVITIES OF A DIABETIC.

    Description of Event or Problem · 1

    THE CUSTOMER'S BG LEVEL IN THE EVENING WAS 115 MG/DL; BOLUSES WERE ADMINISTERED THROUGH THE NIGHT, BUT EARLY THE NEXT MORNING HER LEVELS HAD INCREASED TO 310 MG/DL. OVER THE FOLLOWING 6.5 HOURS, HER LEVELS REMAINED CONSISTENTLY HIGH (287 -318 MG/DL) DESPITE HAVING ADMINISTERED NUMEROUS BOLUSES. SHE REPORTED THAT THE POD HAD INITIATED AN OCCLUSION ALARM. THE DEVICE WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30406

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other