BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1250034 · Received November 14, 2008

    Report

    Report Number
    3004464228-2008-00297
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 15, 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 EVAL CONFIRMED AN INTERNAL LEAK WHICH CAUSED DAMAGE TO THE DEVICE AFTER BEING FILLED 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'S MOTHER CALLED TO SAY, SHE IS UNSURE WHY HER DAUGHTER'S BLOOD GLUCOSE LEVELS (BGS) HAVE BEEN ELEVATED WHILE WEARING THIS POD. HER DAUGHTER'S BG'S FLUCTUATED UP AND DOWN BETWEEN 86 - 277 MG/DL WHILE WEARING THE POD. THE POD EVENTUALLY ALARMED SO THEY DEACTIVATED IT AND STARTED A NEW POD. 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 L11683

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other