BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1011241 · Received March 12, 2008

    Report

    Report Number
    3004464228-2008-00012
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    November 16, 2007
    Report Date
    February 11, 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 POD WAS THOROUGHLY EVALUATED AND NO EVIDENCE OF ANY DAMAGE OR MFG DEFICIENCY WAS FOUND THAT WOULD HAVE EITHER DIRECTLY CAUSED OR CONTRIBUTED TO EITHER INSUFFICIENT OR NO INSULIN DELIVERY. THE DATA DOWNLOADED FROM THE POD SHOWED IT DID NOT EXPERIENCE ELEVATED PRESSURE OR DIFFICULTY PUMPING DUE TO AN OCCLUSION OR OTHER CAUSE. FLUID EXITED THE TIP OF THE CANNULA WHEN THE DRIVE MECHANISM WAS ACTUATED. NO PROBLEM FOUND IN THE RETURNED DEVICE. IT IS UNK WHY THE USER EXPERIENCED HIGH BG LEVELS. THE USER IS INSTRUCTED IN THE USER GUIDE TO PERIODICALLY CHECK THE INFUSION SITE AND TO FREQUENTLY MONITOR THEIR BG LEVELS. BY FOLLOWING THESE RECOMMENDATIONS, THE USER WOULD BECOME AWARE OF HIGH BG LEVELS AND COULD USE ANOTHER DEVICE OR BACKUP THERAPY IF REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT THE POD SHE WAS WEARING MIGHT NOT HAVE BEEN DELIVERING INSULIN. AFTER WEARING THE POD FOR 2 DAYS, SHE EXPERIENCED ELEVATED BG'S IN THE 300'S AND SYMPTOMS OF VOMITING AND LEG PAIN. SHE REMOVED THE POD AT 1 PM OF THE SECOND DAY OF POD WEAR AND BEGAN ADMINISTERING INJECTIONS OF LANTUS AND SHORT ACTING INSULIN. AT 4 PM, SHE WAS ADVISED BY HER HCP THAT SHE MIGHT BE EXPERIENCING DKA. SHE WAS TAKEN TO THE HOSPITAL AND WAS ADMITTED FOR 2 DAYS WITH HIGH KETONE LEVELS. SHE INDICATED THAT THE CANNULA DID NOT APPEAR KINKED OR BENT AND SHE DID NOT REMEMBER SMELLING INSULIN OR THE SITE BEING WET WHEN SHE REMOVED THE POD. THIS INCIDENT OCCURRED A WEEK BEFORE THANKSGIVING WHEN SHE WAS PREPARING FOR AN OPEN HOUSE WHICH SHE WAS HOSTING. CUSTOMER COULD NOT GIVE SPECIFICS REGARDING INSULIN BOLUS AMOUNTS OR BG READINGS. CUSTOMER WENT BACK ONTO INJECTIONS AFTER HER HOSPITAL STAY FOR A PERIOD. NO FURTHER PROBLEMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 11200 L11479

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization