BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1172645 · Received September 19, 2008

    Report

    Report Number
    3004464228-2008-00211
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 25, 2008
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 PARENT CALLED TO REPORT THEIR SON HAD HIGH BLOOD GLUCOSE LEVELS (BG'S) DESPITE GIVING CORRECTION BOLUS INSULIN DOSES. THE BG GOT AS HIGH AS 384 MG/DL BEFORE THEY GAVE A MANUAL INSULIN INJECTION. THE POD EVENTUALLY ALARMED SO THEY TOOK THE POD OFF AND STARTED A NEW ONE SUCCESSFULLY. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11744

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other