BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2212709 · Received July 12, 2011

    Report

    Report Number
    3004464228-2011-00340
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 9, 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 WILL NOT BE RETURNED FOR EVALUATION - WE ARE UNABLE TO IDENTIFY ANY DEVICE MALFUNCTION THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S HIGH BG LEVELS. NO MECHANICAL ISSUE CAN BE CONFIRMED. ALTHOUGH NO MECHANICAL ISSUE CAN BE CONFIRMED, IT IS DETERMINED THAT THE CUSTOMER'S HIGH BG LEVELS HAD RESULTED FROM THE CANNULA PULLING FROM THE INSERTION SITE. THIS CONDITION IS CONSIDERED TO BE A FAILURE OF THE DEVICE TO FUNCTION AS INTENDED (BY FALLING 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 THE INABILITY TO CONFIRM ANY MECHANICAL ISSUE). THE OMNIPOD SYSTEM USER GUIDE WARNS: "CHECK THE INFUSION SITE AFTER INSERTION TO ENSURE THAT THE CANULA 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." BASED ON THE INFORMATION PROVIDED IN THE REPORT, THE CUSTOMER HAD BECOME AWARE THAT THE CANNULA HAD PULLED FROM THE INSERTION SITE BUT CONTINUED TO WEAR THE POD, RESULTING IN HIGH BG LEVELS. IF USER GUIDE INSTRUCTIONS WERE FOLLOWED, THE CUSTOMER WOULD HAVE IMMEDIATELY REMOVED AND REPLACED THE POD UPON NOTICING THAT THE CANNULA WAS NOT INSERTED SUBCUTANEOUSLY. A REVIEW OF LOT QUALIFICATION RECORDS COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER HAD EXPERIENCED AN ELEVATED BG READING OF 230 MG/DL AT DINNER TIME AND A CORRECTION BOLUS WAS ADMINISTERED. HER BG LEVELS WEREN'T CHECKED UNTIL 11PM LATER THAT EVENING - A HIGH BG OF 561 MG/DL WAS EXPERIENCED AT THIS TIME. BECAUSE OF THE INCREASE IN BG'S, THE CUSTOMER'S FATHER FELT THE "POD WAS NOT WORKING." THE FATHER CALLED BACK THE NEXT DAY TO REPORT THAT SHE "FAILED TO INFORM HER PATIENTS" THAT "THE CANNULA HAD COME OUT BEFORE DINNER" THE PREVIOUS DAY; "THEREFORE, HER BG LEVEL CONTINUED TO CLIMB." IN HIS FOLLOW-UP CALL, THE FATHER INDICATED THAT "SHE IS MUCH BETTER TODAY." THE POD WAS NOT SAVED AND WILL THEREFORE NOT 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 UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other