BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2861779 · Received November 6, 2012

    Report

    Report Number
    3004464228-2012-00562
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    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 PRODUCT WAS RETURNED FOR EVAL AND FOUND TO BE FUNCTIONING AS INTENDED. NO MALFUNCTION OR PRODUCT DEFECT FOUND THAT WOULD HAVE CONTRIBUTED TO THE CUSTOMER'S RISING BLOOD GLUCOSE LEVELS. A DISLODGED CANNULA WOULD LIKELY RESULT IN INTERRUPTED INSULIN DELIVERY AND MAY LEAD TO INCREASED BLOOD GLUCOSE. THE LAB EVAL, HOWEVER, CANNOT CONFIRM THAT THE CANNULA HAD DISLODGED FROM THE CUSTOMER'S SKIN AND THEREFORE NO CONCLUSION CAN BE DRAWN. THE LOT WAS REVIEWED AND DETERMINED TO HAVE MET ALL ACCEPTANCE CRITERIA. THE OMNIPOD'S USER GUIDE WARNS TO "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 HRS AFTER EACH POD CHANGE AND TO CHECK THE INFUSION SITE PERIODICALLY. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT." THE USER GUIDE ALSO WARNS, "...IF YOUR EXPERIENCE UNEXPECTED ELEVATED BLOOD GLUCOSE OCCURS, CHANGE YOUR POD."

    Description of Event or Problem · 1

    UPON WALKING UP, CUSTOMER'S BG WAS 390 MG/DL AND HE "FELT WETNESS AND SMELLED INSULIN." THE POD WAS REMOVED AND HE NOTICED THE CANNULA WAS "NOT INSERTED/CAME OUT." POD WAS 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 L30956

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR