BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 2220186 · Received August 16, 2011

    Report

    Report Number
    3004464228-2011-00420
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    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 RETURNED PRODUCT WAS EVALUATED AND FOUND TO BE FUNCTIONING AS INTENDED. A KINK IN THE CANNULA WAS NOTED BUT IT WAS DETERMINED TO HAVE OCCURRED POST-USE SINCE NO OCCLUSION WAS FOUND AND NO ALARM SOUNDED. DESPITE DETERMINING THAT THE PRODUCT DELIVERED INSULIN W/O ANY INTERRUPTION, INDICATING THAT THERE WAS NO BEND IN THE CANNULA, WE ARE UNABLE TO TEST IF THE CANNULA WAS "OUT" OF THE CUSTOMER'S SKIN. BECAUSE THE CUSTOMER REPORTED A HIGH BLOOD GLUCOSE OF 500MG/DL ONLY MINS AFTER DEACTIVATING THE POD THAT APPEARED TO HAVE A DISLODGED CANNULA, IT IS POSSIBLE THAT THE CANNULA CAME OUT OF THE CUSTOMER'S SKIN SOMETIME WITHIN THE 12.5 HRS OF WEARING THE DEVICE; A DISLODGED CANNULA WOULD RESULT IN HIGH BLOOD GLUCOSE LEVELS. DESPITE THIS PLAUSIBLE SCENARIO, WE ARE UNABLE TO MAKE ANY CONCLUSIONS. THE OMNIPOD'S USER GUIDE CAUTIONS TO "CHECK THE INFUSION SITE AFTER INSERTION TO ENSURE THAT THE CANNULA WAS PROPERLY INSERTED. IT IS ALSO A GOOD IDEA TO CHECK YOU BLOOD GLUCOSE ABOUT TWO HRS AFTER EACH POD CHANGE AND TO CHECK THE INFUSION SITE PERIODICALLY." THE LOT WAS FOUND TO HAVE MET ALL ACCEPTANCE CRITERIA. NO FURTHER INTERNAL INVESTIGATION WILL BE CONDUCTED, AS NO PRODUCT PROBLEM WAS FOUND.

    Description of Event or Problem · 1

    A CUSTOMER'S HUSBAND REPORTED THAT WHILE HIS WIFE DEACTIVATED A POD ON (B)(6) 2011 AT 8:58AM, "HE LOOKED THROUGH THE CLEAR VIEW WINDOW OF THE POD AND SAW THE CANNULA OUT AND BENT." THE HUSBAND WAS CONCERNED THAT THE POD DID NOT ALARM. AT 9:02AM, THE CUSTOMER HAD A HIGH BLOOD GLUCOSE LEVEL OF 500MG/DL. THIS POD WAS WORN FOR AT LEAST 12.5 HRS PRIOR TO BEING DEACTIVATED. THE CUSTOMER ACTIVATED A NEW POD AND "WAS FEELING GOOD AND RESTING". THE DEVICE WILL BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30477

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR