BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2251309 · Received August 12, 2011

    Report

    Report Number
    3004464228-2011-00405
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 12, 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

    THE PRODUCT WILL NOT BE RETURNED FOR EVAL. A BEND IN THE CANNULA WOULD RESULT IN INTERRUPTED INSULIN DELIVERY AND CAUSE ELEVATED BLOOD GLUCOSE LEVELS. ADDITIONALLY, A BEND WOULD CREATE AN OCCLUSION IN THE CANNULA AND SOUND AN ALARM, HOWEVER, NO ALARM WAS REPORTED. BECAUSE THE DEVICE WAS NOT RETURNED, WE ARE UNABLE TO CONCLUSIVELY STATE WHETHER THE PRODUCT HAD ANY MALFUNCTION OR DEFECT THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S HIGH BLOOD GLUCOSE. THE OMNIPOD'S USER GUIDE CAUTIONS USERS 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 HOURS AFTER EACH POD CHANGE AND TO CHECK THE INFUSION SITE PERIODICALLY." THE LOT WAS FOUND TO HAVE MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER ACTIVATED A DEVICE ON (B)(6) 2011 AT 11:09PM. THE FOLLOWING DAY, AT 5:38AM, SHE EXPERIENCED A BLOOD GLUCOSE OF 258MG/DL, BY 2:37PM IT HAD DECREASED TO 149MG/DL, BUT THEN ROSE AGAIN TO 244MG/DL AT 6:00PM. AT 8:00 PM, HER BLOOD GLUCOSE REACHED A HIGH LEVEL OF 495 MG/DL SO SHE GAVE HERSELF A BOLUS DOES OF INSULIN (9.6 UNITS). AT 9:30 PM SHE EXPERIENCED A "HIGH" BLOOD GLUCOSE LEVEL AND DECIDED TO DEACTIVATE THE POD BECAUSE "AFTER GIVING SO MUCH INSULIN HER [BLOOD GLUCOSE LEVELS] WERE NOT LOWERING." WHILE REMOVING THE DEVICE, THE CUSTOMER NOTICED THE CANNULA APPEARED BENT. THE PRODUCT WAS NOT 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 L30527

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR