BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2844946 · Received October 24, 2012

    Report

    Report Number
    3004464228-2012-00531
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 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

    THE POD WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION OR DEFECT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER'S HIGH BGAS. A DISLODGED CANNULA WOULD LIKELY IMPEDE INSULIN DELIVERY AND MAY LEAD TO HYPERGLYCEMIA. THE LAB, HOWEVER, CANNOT CONFIRM THAT THE CANNULA HAD DISLODGED FROM THE CUSTOMER'S SKIN AND THEREFORE, NO CONCLUSION CAN BE DRAWN. A KINKED CANNULA WOULD LIKELY LEAD TO HYPERGLYCEMIA, HOWEVER, THIS CANNOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED. 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." ADDITIONALLY, THE USER GUIDE ADVISES THAT CUSTOMERS CAN AVOID HYPER GLYCEMIA BY CHECKING BLOOD GLUCOSE LEVELS AT LEAST 4 TO 6 TIMES A DAY. AFTER A TOTAL OF 4 HOURS OF MONITORING AND ADMINISTERING CORRECTION BOLUSES, IF BGS STILL REMAIN HIGH THE USER GUIDE INSTRUCTS TO CHANGE THE POD USING A NEW VIAL OF INSULIN AND CONTACT AN HCP FOR GUIDANCE. PRODUCT LOT QUALIFICATION RECORDS WERE REVIEWED AND FOUND TO HAVE MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    CUSTOMER'S BG ROSE INTO THE 300S MG/DL WHEN SHE REALIZED THE "CANNULA PULLED OUT OF HER SKIN." SHE ALSO REPORTED THE CANNULA APPEARED "KINKED." THE POD IS NOT EXPECTED TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSINO, INSULIN LZG INSULET CORPORATION 11200 L30933

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR