BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2864565 · Received November 8, 2012

    Report

    Report Number
    3004464228-2012-00567
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Date of Event
    October 10, 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

    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 BGS. A DISLODGED CANNULA WOULD IMPEDE INSULIN DELIVERY AND MAY LEAD TO HYPERGLYCEMIA. THE LAB, HOWEVER, HOWEVER, CANNOT CONFIRM THAT THE CANNULA HAD DISLODGED FROM THE CUSTOMER'S SKIN AND THEREFORE NO CONCLUSION CAN BE DRAWN. 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 HYPERGLYCEMIA 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 WAS 496 MG/DL AND WHEN SHE TRIED BOLUSING SHE "NOTICED BLOOD IN THE CANNULA WINDOW AND...THE CANNULA WAS NOT INSERTED." THE POD WAS NOT RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30891

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR