BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2212710 · Received July 12, 2011

    Report

    Report Number
    3004464228-2011-00337
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 10, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POD WAS NOT 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. NOTE: AFTER A CORRECTION BOLUS WAS ADMINISTERED IN RESPONSE TO A HIGH BG OF 344 MG/DL, THE CUSTOMER'S LEVELS HAD LOWERED TO 243 MG/DL THREE HOURS LATER. THIS IS AN INDICATION THAT THE CUSTOMER HAD BEEN RECEIVING INSULIN UP TO THIS POINT, AND THAT THE CANNULA MAY NOT HAVE "COME OUT OF THE SKIN" UNTIL AFTER THE HIGH BG LEVELS WERE EXPERIENCED. THE CANNULA PULLING FROM THE SKIN MAY THEREFORE NOT HAVE BEEN A CONTRIBUTING FACTOR TO HIGH BG LEVELS, THOUGH THIS CANNOT BE CONFIRMED (AS THE CUSTOMER DID NOT PROVIDE BG HISTORY BEYOND THIS TIME). IT IS UNKNOWN IF HIGH BG LEVELS HAD BEEN EXPERIENCED AFTER THE REPORTED HIGH READING OF 344 MG/DL. ALTHOUGH NO MECHANICAL ISSUE CAN BE CONFIRMED, IT IS DETERMINED THAT THE CUSTOMER'S HIGH BG LEVELS HAD RESULTED FROM THE CANNULA "POPPING OUT" FROM THE INSERTION SITE. 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 THE INABILITY TO CONFIRM ANY MECHANICAL ISSUE). 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. A REVIEW OF LOT QUALIFICATION RECORDS WAS PERFORMED - THE LOT PASSED THE ACCEPTANCE CRITERIA. NOTE: EVALUATION METHOD ARE SPECIFIC TO ACTIVITIES PERFORMED DURING LOT QUALIFICATION AND NOT TO ACTIVITIES PERFORMED ON THE SUBJECT POD (AS IT WAS NOT RETURNED FOR EVALUATION). EVALUATION CONCLUSIONS PERTAINS TO A FAILURE OF THE CANNULA TO REMAIN INSERTED IN THE CUSTOMER'S SKIN (NOT TO A "MECHANICAL" FAILURE DETECTED DURING TESTING, AS THE POD WAS NOT RETURNED).

    Description of Event or Problem · 1

    THE CUSTOMER HAD EXPERIENCED AN ELEVATED BG LEVEL OF 224 MG/DL; A CORRECTION BOLUS WAS ADMINISTERED IN RESPONSE. HOWEVER, 5.5 HOURS LATER HIS BG'S HAD RISEN TO 344 MG/DL; A SECOND CORRECTION BOLUS WAS THEN ADMINISTERED. WITHIN THREE HOURS HIS LEVELS LOWERED TO 243 MG/DL. HE STATED THAT "THE ADHESIVE ON THE POD WAS WEARING OFF IN FRONT OF THE POD" WHICH CAUSED "THE CANNULA TO COME OUT OF THE SKIN AND HIS BG'S TO RISE." THE DEVICE WILL 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 L30517

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other