BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2220163 · Received August 16, 2011

    Report

    Report Number
    3004464228-2011-00421
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 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

    BECAUSE THE PRODUCT WILL NOT BE RETURNED FOR EVAL, WE ARE UNABLE TO IDENTIFY ANY DEVICE MALFUNCTION THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S "HIGH" BLOOD GLUCOSE READING. NO MECHANICAL ISSUE CAN BE CONFIRMED. ALTHOUGH WE CANNOT CONFIRM A MECHANICAL ISSUE, IT IS DETERMINED THAT THE CUSTOMER'S "HIGH" BLOOD GLUCOSE LEVEL HAD RESULTED FROM THE "DISLODGED" CANNULA. THIS CONDITION IS CONSIDERED TO BE A FAILURE OF THE DEVICE TO PERFORM ITS ESSENTIAL FUNCTION OF DELIVERING INSULIN TO REDUCE BLOOD GLUCOSE LEVELS. THE OMNIPOD'S USER GUIDE WARN 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." BASED ON THE INFO PROVIDED IN THE REPORT, IT IS UNK WHEN THE CANNULA HAD BECOME DISLODGED IN RELATION TO WHEN BLOOD GLUCOSE LEVELS BEGAN TO INCREASE. NOTE: EVAL CONCLUSIONS CODE PERTAINS TO A FAILURE OF THE CANNULA TO REMAIN INSERTED IN THE CUSTOMER'S SKIN (NOT TO A MECHANICAL FAILURE DETECTED DURING TESTING, THE POD WAS RETURNED).

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER CALLED TO REPORT THAT WHILE HER DAUGHTER WAS AT CAMP, HER PDM REGISTERED A "HIGH" BLOOD GLUCOSE. WHEN THE CAMP STAFF CHANGED THE DEVICE FOR HER, THEY NOTICED "THE CANNULA HAD BECOME DISLODGED AND INSULIN WAS ON HER CLOTHING." THE CUSTOMER SUCCESSFULLY ACTIVATED A NEW POD AND ADMINISTERED A BOLUS DOSE OF INSULIN TO LOWER HER BLOOD GLUCOSE LEVELS. INSULET'S CUSTOMER CARE ADVISED FOR THE CUSTOMER TO MONITOR HER BLOOD SUGAR LEVELS CLOSELY FOR THE NEXT TWO HRS TO MAKE SURE THERE IS A DECLINE. THE PRODUCT WILL NOT BE RETURNED FOR INVESTIGATION.

    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