BEUDAMED
    FDA Adverse Event Other Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 791919 · Received December 4, 2006

    Report

    Report Number
    3004464228-2006-00007
    Event Type
    Other
    Date Received
    December 4, 2006
    Date of Event
    November 5, 2006
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SYMPTOMS OF HYPERGLYCEMIA AND DKA APPROXIMATELY 23 HOURS AFTER ACTIVATING A NEW POD. HE WAS ADMITTED TO THE HOSPITAL AND GIVEN INTRAVENOUS INSULIN. AT SOME POINT DURING HIS TREATMENT, HE REMOVED HIS POD AND DISPOSED OF IT, SO IT IS NOT AVAILABLE FOR EVALUATION BY THE MANUFACTURER. THE PATIENT IS NO LONGER USING THE PRODUCT.

    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 60 YR Hospitalization| R