BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2251799 · Received August 31, 2011

    Report

    Report Number
    3004464228-2011-00495
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 8, 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 FOR EVALUATION - NO MECHANICAL PROBLEMS WERE FOUND THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S HIGH BG LEVELS. THE POD FUNCTIONED AS DESIGNED MECHANICALLY DURING TESTING. ALTHOUGH NO MECHANICAL ISSUES WERE FOUND DURING THE EVALUATION, IT IS DETERMINED THAT THE CUSTOMER'S HIGH BG LEVELS HAD RESULTED FROM THE CANNULA POTENTIALLY PULLING OUT FROM 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 SYSTEM USER GUIDE WARNS: "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." A REVIEW OF LOT QUALIFICATION RECORDS WAS PERFORMED - THE LOT PASSED THE ACCEPTANCE CRITERIA. NOTE: EVALUATION RESULTS CODE PERTAINS TO THE MECHANICAL PERFORMANCE RESULTS OF THE POD. EVALUATION CONCLUSIONS CODE PERTAIN 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'S MOTHER CALLED TO REPORT THAT HER DAUGHTER HAD EXPERIENCED HIGH BG LEVELS WITHIN THE FIRST DAY OF WEARING THE POD. HER "AVERAGE" BG LEVEL WITH THIS POD WAS 350 MG/DL. BLOOD WAS SEEN IN THE CANNULA AND THE ADHESIVE WAS WET - THE MOTHER BELIEVED THAT THE CANNULA HAD PULLED OUT OF THE INSERTION SITE. SHE HAD ADMINISTERED CORRECTION BOLUSES IN RESPONSE TO THE HIGH BG'S, BUT LEVELS WOULD ONLY "COME DOWN A LITTLE" (SPECIFIC READINGS WERE NOT PROVIDED). 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 L30531

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other