BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3240511 · Received July 15, 2013

    Report

    Report Number
    3004464228-2013-00765
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    June 16, 2013
    Report Date
    June 16, 2013
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED AND PERFORMED AS INTENDED. THE CANNULA TIP WAS ROUND IN SHAPE AND NOT FLATTENED. NO DEFECT OR DEFICIENCY THAT WOULD RESULT IN THE CANNULA FAILING TO INSERT CORRECTLY OR THE PUMP FAILING TO DELIVER INSULIN WAS FOUND. THE CUSTOMER THOUGHT THAT THE CANNULA HAD NOT INSERTED PROPERLY. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTED TO HYPERGLYCEMIA. IT CANNOT BE CONFIRMED, NOR CONCLUSIVELY EXCLUDED THROUGH LABORATORY TESTING. THE OMNIPOD 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," "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA)," AND "IF YOUR READING IS ABOVE 500 MG/DL, THE PDM DISPLAYS 'HIGH CHECK FOR KETONES!' THIS INDICATES SEVERE HYPERGLYCEMIA (HIGH BLOOD GLUCOSE). IF YOU GET A 'HIGH CHECK FOR KETONES!' READING AND FEEL SYMPTOMS SUCH AS FATIGUE, THIRST, EXCESS URINATION, OR BLURRY VISION, FOLLOW YOUR HEALTHCARE PROVIDER'S RECOMMENDATION TO TREAT HYPERGLYCEMIA." QUALIFICATION RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE ACTIVATED THE POD AT 7:10 AM. SHE DEACTIVATED THE DEVICE. SHE THINKS THE CANNULA WAS NOT PROPERLY INSERTED BECAUSE IT WAS FLAT AGAINST THE ADHESIVE WHEN SHE REMOVED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327799 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L31085

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR