BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2212808 · Received July 12, 2011

    Report

    Report Number
    3004464228-2011-00341
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 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 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. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT." BASED ON THE INFORMATION PROVIDED IN THE REPORT, IT IS UNKNOWN WHEN THE CANNULA HAD "PULLED OUT" IN RELATION TO WHEN BG LEVELS BEGAN TO INCREASE. A REVIEW OF LOT QUALIFICATION RECORDS WAS PERFORMED - THE LOT PASSED THE ACCEPTANCE CRITERIA. NOTE: EVALUATION METHOD 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'S MOTHER REPORTED THAT HER DAUGHTER'S "CANNULA WAS PULLED OUT AND THEY COULD SMELL INSULIN." A HIGH BG LEVEL OF 378 MG/DL WAS EXPERIENCED WHILE THIS POD WAS WORN. THE POD WAS REMOVED BECAUSE SHE "FELT HIGH"; 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 L30526

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other