BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2211269 · Received July 12, 2011

    Report

    Report Number
    3004464228-2011-00351
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 12, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE POD WAS RETURNED FOR EVAL (NO MECHANICAL PROBLEMS WERE FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S HIGH BG LEVELS). DESPITE THE REPORTED "LIGHT BEND" IN THE CANNULA, NO OBSTRUCTION OF THE FLUID PATH WAS FOUND. THE POD DID NOT OCCLUDE AND THE CUSTOMER WOULD HAVE RECEIVED ALL PROGRAMMED DOSES OF INSULIN (HAD THE CANNULA BEEN INSERTED SUBCUTANEOUSLY). THE POD FUNCTIONED AS DESIGNED DURING TESTING. ALTHOUGH NO MECHANICAL ISSUES WERE FOUND DURING THE EVALUATION, IT IS DETERMINED THAT THE CUSTOMER'S HIGH BG LEVELS HAS RESULTED FROM THE CANNULA "POKING OUT OF THE SKIN." THIS CONDITION IS CONSIDERED TO BE A FAILURE OF THE DEVICE TO FUNCTION AS INTENDED (BY FAILING TO CONTROL BG LEVELS). FOR THIS REASON, WE ARE CONSIDERING A DEVICE MALFUNCTION TO HAVE BEEN A CONTRIBUTING FACTOR TO THE CUSTOMER'S HIGH BG LEVELS (DESPITE TEST RESULTS THAT SHOW IT OPERATED MECHANICALLY AS DESIGNED). THE OMNIPOD USER GUIDE WARNS "CHECK THE INFUSION SITE AFTER INSERTION TO ENSURE THAT THE CANNULA WAS PROPERLY INSERTED." IF USER GUIDE INSTRUCTIONS WERE PROPERLY FOLLOWED, THE USER WOULD HAVE IMMEDIATELY NOTICED THAT THE CANNULA HAD NOT DEPLOYED (WHICH WOULD HAVE BEEN VISIBLE THROUGH THE VIEWING WINDOW) AND WOULD NOT HAVE PROCEEDED TO WEAR THE POD. THE USER GUIDE ALSO WARNS THE USER TO "CHECK THE INFUSION SITE OFTEN TO MAKE SURE THE POD AND SOFT CANNULA ARE SECURELY APPLIED AND IN PLACE, IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT." A REVIEW OF LOT QUALIFICATION RECORDS WAS PERFORMED. THE LOT PASSED THE ACCEPTANCE CRITERIA. NOTE: EVALUATION RESULTS PERTAIN TO THE MECHANICAL PERFORMANCE RESULTS OF THE POD. EVAL CONCLUSIONS PERTAINS TO A FAILURE OF THE CANNULA TO REMAIN INSERTED IN THE CUSTOMER'S SKIN (NOT TO A "MECHANICAL" FAILURE).

    Description of Event or Problem · 1

    THE CUSTOMER HAD EXPERIENCED CONSISTENTLY HIGH BG LEVELS (274 - 400 MG/DL) THROUGHOUT THE DURATION OF POD WEAR (25 HOURS). NUMEROUS CORRECTION BOLUSES WERE ADMINISTERED DURING THIS TIME, THOUGH HIS BGS FAILED TO LOWER TO WITHIN TARGET RANGE. HE REPORTED THAT THE "CANNULA WOULD POKE OUT OF THE SKIN AND WAS SLIGHTLY BENT." THE POD WAS DEACTIVATED AFTER A HIGH READING OF 400 MG/DL 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 L30507

    Patients

    Seq Age Sex Outcome Treatment
    1 Other