BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2112372 · Received May 25, 2011

    Report

    Report Number
    3004464228-2011-00236
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 1, 2011
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POD WILL NOT BE RETURNED FOR EVAL - WE ARE UNABLE TO CONFIRM ANY DEVICE MALFUNCTION THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S HIGH BG LEVELS. BASED ON THE ABSENCE OF A TIME LINE PROVIDED IN THE REPORT, IT IS UNK WHEN THE CANNULA HAD PULLED FROM THE INSERTION SITE IN RELATION TO WHEN HIS BG LEVELS BEGAN TO RISE. NO CONCLUSION CAN BE DRAWN. NOTE: THE REPORT INDICATED THAT "CONDENSATION" WAS SEEN IN THE VIEWING WINDOW - THE PRESENCE OF CONDENSATION HAS NO IMPACT ON THE FUNCTIONALITY OF THE POD AND WOULD NOT HAVE AFFECTED THE CUSTOMER'S BG LEVELS. 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." BY FOLLOWING USER GUIDE INSTRUCTIONS, THE CUSTOMER WOULD HAVE IMMEDIATELY REMOVED AND REPLACED THE POD UPON NOTICING THAT THE CANNULA WAS NOT INSERTED INTO HIS SKIN. NO LOT NUMBER WAS PROVIDED - A REVIEW OF LOT QUALIFICATION RECORDS WAS THEREFORE, UNABLE TO BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER'S GRANDMOTHER REPORTED THAT "THERE WAS CONDENSATION" IN THE VIEWING WINDOW OF THE POD. UPON FURTHER INSPECTION OF THE WINDOW, SHE NOTICED THAT THE CANNULA "WAS NOT IN"; A POTENTIAL CAUSE OF THE CANNULA PULLING FROM THE INSERTION SITE WAS NOT STATED. DURING THE FIRST DAY, THIS POD WAS WORN, THE CUSTOMER EXPERIENCED BG LEVELS GREATER THAN 500MG/DL WITH LARGE KETONES. THE POD WILL NOT BE RETURNED FOR EVAL.

    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 5 YR Other