BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2861783 · Received November 6, 2012

    Report

    Report Number
    3004464228-2012-00563
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 10, 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

    A CANNULA THAT DOES NOT DEPLOY PROPERLY INDICATES A NEEDLE MECHANISM FAILED TO FUNCTION AS DESIGNED. THIS WOULD LIKELY CONTRIBUTE TO THE CUSTOMER'S HYPERGLYCEMIA, HOWEVER, SINCE THE POD WAS NOT RETURNED FOR EVAL NO MALFUNCTION CAN BE CONFIRMED. PRODUCT LOT RECORDS COULD NOT BE REVIEWED SINCE NO LOT NUMBER WAS REPORTED. 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 YOU EXPERIENCE UNEXPECTED, ELEVATED BLOOD GLUCOSE, CHANGE YOUR POD."

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POD WHOSE CANNULA "DID NOT INSERT PROPERLY CAUSING INSULIN TO DELIVER OUTSIDE HER BODY". SHE STATED THE ADHESIVE WAS WET AFTER ACTIVATING THE POD. HER BG WAS "OVER 600 MG/DL." THE POD WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR