BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1092904 · Received August 1, 2008

    Report

    Report Number
    3004464228-2008-00158
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    June 24, 2008
    Report Date
    July 2, 2008
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IDENTIFYING INFORMATION FOR THE DEVICE WAS NOT AVAILABLE. NO OTHER EVALUATION IS POSSIBLE. NO CONCLUSION IS POSSIBLE. THE PRODUCT USER GUIDE INSTRUCTS THE USER TO WASH THEIR HANDS AND USE ASEPTIC TECHNIQUE TO PREPARE THE INFUSION SITE BEFORE APPLYING THE POD. IT ALSO INSTRUCTS THEM TO "CHECK INFUSION SITE AT LEAST ONCE A DAY FOR SIGNS OF INFECTION AND TO INSURE THAT THE SOFT CANNULA IS SECURELY IN PLACE".

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT AN INFECTION AT THE INSERTION SITE. SHE SAID SHE ACTIVATED THE POD IN 2008, AT ABOUT 9PM. BY EVENING OF TWO DAYS LATER, IT STARTED TO HURT NEAR THE INSERTION SITE. SHE DIDN'T THINK MUCH OF IT AT THE TIME SINCE SHE HAD BEEN USING THE SYSTEM FOR 2 YEARS AND HAS HAD OTHER INSTANCES WHERE IT FELT A BIT UNCOMFORTABLE DUE TO THE PLACEMENT OF THE POD. SHE REMOVED THE POD THAT MORNING AND NOTED A VERY HARD RED BUMP UNDER THE SKIN THAT WAS VERY HOT TO TOUCH. SHE SAID THAT PUSS CAME OUT OF THE SITE WHEN THE POD WAS REMOVED. SHE WENT TO THE DOCTOR AND WAS GIVEN ANTIBIOTICS FOR THE INFECTION. SHE HAD A BLOOD TEST AND HAD ELEVATED WHITE CELL COUNT. SHE WAS WEARING THE POD ON HER ARM. SHE ROTATES SITES BETWEEN BOTH ARMS. CLEANS THE SITE CAREFULLY WITH ALCOHOL BEFORE APPLYING THE POD. SHE HAD THROWN THE POD AWAY SO IT WAS NOT AVAILABLE TO BE RETURNED. NO FURTHER INFORMATION REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention