BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1081597 · Received July 25, 2008

    Report

    Report Number
    3004464228-2008-00145
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 15, 2008
    Report Date
    June 26, 2008
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION. AS REPORTED THE CANNULA WAS NOT IN THE INFUSION SITE WHEN IT WAS REMOVED. UNABLE TO DETERMINE IF IT WAS NOT PROPERLY PLACED OR HAD COME OUT AFTER PLACEMENT. NO CONCLUSION CAN BE REACHED AT THIS TIME. 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 IN POD THAT SHE HAD PUT. ON THE NEXT DAY, SHE WOKE UP VERY SICK, BGS READ HIGH ON THE PDM AND SHE WAS HOSPITALIZED. AT THE HOSPITAL, THEY REMOVED THE POD AND SAW THAT THE CANNULA HADN'T BEEN IN HER SKIN. CUSTOMER SAID THAT THE HOSPITAL PUT HER ON AN IV. CUSTOMER WAS IN THE HOSPITAL THROUGH THE FOLLOWING DAY. 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 L11689

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization