BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2760012 · Received September 21, 2012

    Report

    Report Number
    3004464228-2012-00469
    Event Type
    Malfunction
    Date Received
    September 21, 2012
    Date of Event
    August 24, 2012
    Report Date
    August 24, 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 BENT CANNULA HAS THE POTENTIAL TO RESTRICT INSULIN DELIVERY AND MAY RESULT IN HYPERGLYCEMIA. HOWEVER, SINCE THE POD WAS NOT RETURNED, WE CANNOT CONFIRM ANY PRODUCT MALFUNCTION OR DEFECT THAT MAY HAVE CONTRIBUTED TO THE CUSTOMER'S HYPERGLYCEMIA. 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 HOURS AFTER EACH POD CHANGE AND TO CHECK THE INFUSION SITE PERIODICALLY. IF THE CANNULA IS NOT PROPERLY INSERTED, HYPERGLYCEMIA MAY RESULT." THE USER GUIDE WARNS THAT "TEST RESULTS GREATER THAN 250 MG/DL MEAN HIGH BLOOD GLUCOSE (HYPERGLYCEMIA)," AND ADVISES TO TREAT HYPERGLYCEMIA FIRST BY CHECKING FOR KETONES. IF KETONES ARE PRESENT, FOLLOW THE GUIDANCE OF A HCP. IF KETONES ARE NOT PRESENT, TAKE A CORRECTION BOLUS AS PRESCRIBED BY A HCP. CHECK BLOOD GLUCOSE AGAIN AFTER TWO HOURS. IF BG LEVELS HAVE NOT DECREASED THEN TAKE A SECOND BOLUS BY INJECTION, USING A STERILE SYRINGE. IF BGS REMAIN HIGH AFTER A TOTAL OF 4 HOURS THEN REPLACE THE POD AND CONTACT A HCP FOR GUIDANCE. LOT QUALIFICATION RECORDS WERE REVIEWED AND DETERMINED TO HAVE PASSED ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    CUSTOMER PLACED POD "PRETTY CLOSE TO BELT LINE." SHE WAS STANDING UP WHILE APPLYING THE POD AND IT WAS PLACED HORIZONTALLY. AROUND 10 AM, ON THE SECOND DAY OF POD WEAR, HER BG READ 380 MG/DL. A COUPLE HOURS LATER, AROUND LUNCH TIME, HER BG WAS 422 MG/DL. HER BG EVENTUALLY GOT AS HIGH AS 465 MG/DL SO SHE REMOVED THE POD. CUSTOMER STATED "THE CANNULA IS BEND DOWNWARDS." THE POD WAS NOT RETURNED DUE TO THE CUSTOMER TAKING THE POD APART" TO SEE WHAT THE POD LOOKED LIKE INSIDE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30890

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR