BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2112370 · Received May 25, 2011

    Report

    Report Number
    3004464228-2011-00230
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 28, 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. NO TIME LINE WAS PROVIDED IN THE REPORT - IT IS UNK WHEN THE CANNULA HAD "POPPED OUT OF THE SITE" IN RELATION TO WHEN HIS BG LEVELS BEGAN TO RISE. NO CONCLUSION CAN BE DRAWN. 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. A REVIEW OF LOT QUALIFICATION RECORDS WAS PERFORMED AND THE LOT HAD PASSED THE ACCEPTANCE CRITERIA. (NOTE: EVAL METHOD CODES ARE SPECIFIC TO ACTIVITIES PERFORMED DURING LOT QUALIFICATION, NOT TO ACTIVITIES PERFORMED ON THE SUBJECT POD AS IT WAS NOT RETURNED FOR EVAL).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HIS BG LEVELS "HAD BEEN READING IN THE 400'S" THE FIRST DAY OF WEARING THE POD. HE WENT TO CHANGE THE POD AND "NOTICED THE CANNULA HAD POPPED OUT OF THE SITE." NO REASON WAS PROVIDED AS TO WHY THE CANNULA MAY HAVE BECOME DISPLACED. NO SPECIFIC FAILURE MODE WAS CITED. 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 L30467

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other