BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1081592 · Received July 25, 2008

    Report

    Report Number
    3004464228-2008-00143
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION CONFIRMED AN INTERNAL LEAK WHICH CAUSED DAMAGE TO THE DEVICE AFTER BEING FILLED WITH INSULIN. THIS CAUSED THE SUBSEQUENT ALARM INTENDED TO ALERT THE USER TO THE PROBLEM. THE USER IS INSTRUCTED IN THE USER GUIDE TO FREQUENTLY MONITOR THEIR BG LEVELS. BY FOLLOWING THIS RECOMMENDATION, THE USER WOULD BECOME AWARE OF HIGH BG LEVELS AND COULD USE ANOTHER DEVICE OR BACKUP THERAPY IF REQUIRED. THE LOT WAS FOUND TO HAVE MET ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    A CUSTOMER CALLED TO REPORT A POD THAT HE FELT MAY HAVE NOT BEEN DELIVERING INSULIN. THE INFUSION SITE WAS FINE, AND NO DAMAGE TO CANNULA WAS NOTED AFTER REMOVAL. THE POD WAS IN USE FOR APPROXIMATELY 8 HOURS WHEN IT DEACTIVATED AND ALARMED WHILE HE WAS IN THE SHOWER, HIS PDM WAS NOT THERE AT THE TIME. HIS BG WAS 418 AT THE TIME. THE CUSTOMER STATED THAT THIS TIME HE WAS CONCERNED ABOUT HIS BG BEING "SO HIGH", AND HE WENT TO THE ER. HE WAS THERE FOR ABOUT 4 HOURS, RECEIVED I.V. FLUIDS FOR DEHYDRATION, AND NO INSULIN. THE POD WAS REMOVED IN THE ER. WHEN HE LEFT HIS BG WAS 150. HE WAS ABLE TO ACTIVATE AND PLACE A NEW POD, AND HI BG REMAINED NORMAL. NO FURTHER PROBLEMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION OMNIPOD FINAL STERILE L11644

    Patients

    Seq Age Sex Outcome Treatment
    1 Other