BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1243186 · Received November 10, 2008

    Report

    Report Number
    3004464228-2008-00296
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 14, 2008
    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 EVALUATION CONFIRMED AN INTERNAL LEAK WHICH CAUSED DAMAGE TO THE DEVICE AFTER BEING FILED WITH INSULIN. THE USER IS INSTRUCTED IN THE USER GUIDE TO FREQUENTLY MONITOR THEIR BG LEVELS. BY FOLLOWING THIS RECOMMENDATION, THE USER WAS AWARE OF HIGH BG LEVELS AND WAS ABLE TO START A NEW POD SUCCESSFULLY. THE LOT WAS FOUND TO HAVE MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A POD THAT RESULTED IN HER HAVING ELEVATED BLOOD GLUCOSE (BG) READINGS WHILE WEARING IT. HER BG'S RANGED 110 MG/DL - HIGH BEFORE REMOVING THE POD AND STARTING A NEW ONE. CUSTOMER STATED THE CANNULA WAS IN AT TIME OF WEARING AND IT DID NOT APPEAR TO BE KINKED WHEN SHE HAD TAKEN IT OFF. NO FURTHER ISSUES WERE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L30033

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other