BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2861774 · Received November 6, 2012

    Report

    Report Number
    3004464228-2012-00564
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 9, 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 KINKED CANNULA HAS THE POTENTIAL TO RESTRICT INSULIN DELIVERY AND MAY RESULT IN HYPERGLYCEMIA. SINCE THE POD WAS NOT RETURNED, HOWEVER, 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 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 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 AN HCP. IF KETONES ARE NOT PRESENT, TAKE A CORRECTION BOLUS AS PRESCRIBED BY AN HCP. CHECK BLOOD GLUCOSE AGAIN AFTER TWO HRS. 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 HRS THEN REPLACE THE POD AND CONTACT AN HCP FOR GUIDANCE. LOT QUALIFICATION RECORDS WERE REVIEWED AND DETERMINED TO HAVE ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    CUSTOMER'S BG WAS 185 MG/DL WHEN THE POD WAS ACTIVATED AT 6 PM. TWO HRS LATER, HER BG WAS 303 MG/DL. IT CONTINUED TO RISE AND BY 1 AM, HER BG WAS 500 MG/DL. THE POD WAS STILL ON AT 5:30 AM, AND BG WAS READING 500 MG/DL. SHE REMOVED THE POD AT THAT TIME AND SHE STATED THERE WAS A "VISIBLE KINK IN THE CANNULA." THE POD IS NOT EXPECTED TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30826

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR