BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1172644 · Received September 19, 2008

    Report

    Report Number
    3004464228-2008-00216
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 28, 2008
    Report Date
    August 29, 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 CALLED TO REPORT HAVING HIGH BLOOD GLUCOSE LEVELS (BG'S) AND WAS UNABLE TO CONTROL BG WITH BOLUS INSULIN DOSES. HIS BG'S RANGED 97 - 291 MG/DL. HE WAS ABLE TO SEE THE CANNULA AND STATED THAT IT IS IN. CUSTOMER REMOVED THE POD WHILE ON THE PHONE AND NOTICED A DISCOLORATION INSIDE OF POD AND DESCRIBED THE COLOR AS DARK. HE DENIED HEARING ANY CRACKLING NOISES DURING FILL AND DID NOT NOTICE ANY RESISTANCE DURING FILLING PROCESS. CUSTOMER WAS ABLE TO ACTIVATE A NEW POD SUCCESSFULLY AND HIS BG HAS STABILIZED TO NORMAL LIMITS OF 75 - 120 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11809

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other