BEUDAMED
    FDA Adverse Event Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1287123 · Received January 6, 2009

    Report

    Report Number
    3004464228-2009-00009
    Date Received
    January 6, 2009
    Date of Event
    November 6, 2008
    Report Date
    December 12, 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 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 SHE DID NOT BELIEVE HER POD WAS WORKING. CUSTOMER STATED THAT SHE ACTIVATED THE POD AT 1:20 P.M. CUSTOMER STATED THE CANNULA WAS INSERTED CORRECTLY AND THE SITE LOOKED NORMAL. HER BLOOD GLUCOSE LEVELS RANGED BETWEEN 172-500 MG/DL OVER THE 8 HOURS SHE WORE THIS POD. SHE TOOK THIS POD OFF AND STARTED A NEW ONE SUCCESSFULLY. 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 L30008

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other