BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 1063128 · Received June 20, 2008

    Report

    Report Number
    3004464228-2008-00114
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 21, 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 INVOLVED HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION AS OF THE REPORT DATE. A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE PRODUCT IS SUBSEQUENTLY RECEIVED. UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION. NO CONCLUSION CAN BE REACHED AT THIS TIME. THE PRODUCT USER GUIDE INSTRUCTS THE USER TO CHECK THEIR BLOOD GLUCOSE LEVELS FREQUENTLY, SO THAT THEY CAN NOTICE AND REACT QUICKLY AND APPROPRIATELY TO ANY ISSUES.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER CALLED TO REPORT THAT HER SON'S POD WAS NOT DELIVERING INSULIN. CUSTOMER IS CURRENTLY IN THE HOSPITAL DUE TO HIGH BLOOD SUGARS. HE HAD 4 PODS THAT HE USED, AND HIS BLOOD SUGARS RAN HIGH (HIGH REGISTERING ON PDM) ON 3 OF THEM. THE THREE PODS WITH HIGH READINGS, WERE THROWN AWAY. I DID GET SOME HISTORY ON THE 4TH POD. CUSTOMER IS CURRENTLY WEARING THIS POD ON HIS LEG, BUT IT IS IN DOUBT THAT THIS POD IS DELIVERING INSULIN. CUSTOMER WILL REMOVE THIS POD, AND RETURN IT TO US FOR EVALUATION. 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 111619

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization