BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN PUMP

    MDR report key: 3862995 · Received June 5, 2014

    Report

    Report Number
    3004464228-2014-00773
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 9, 2014
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K122953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM ANY PRODUCT MALFUNCTION OR OTHER PRODUCT CONDITION TO HAVE CONTRIBUTED TO THE PATIENT'S KETOACIDOSIS AND HOSPITALIZATION. NO PRODUCT LOT NUMBER WAS REPORTED THEREFORE NO QUALIFICATION RECORDS WERE REVIEWED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT IN (B)(6) HER BLOOD GLUCOSE WAS READING BETWEEN 250 MG/DL TO 350 MG/DL WITH KETONES READING OF OVER 160. HER LEG AND HER STOMACH WERE HURTING AND NOTICED HER BREATH SMELLED "FRUITY". ABOUT A FEW HOURS LATER SHE DECIDED TO GO TO THE HOSPITAL AND UPON ARRIVAL SHE WAS ADMITTED FOR DIABETIC KETOACIDOSIS. THEY TREATED HER WITH FLUIDS AND INSULIN INTRAVENOUSLY. SHE STAYED IN THE HOSPITAL FOR THE NEXT 3 DAYS BEFORE BEING RELEASED. SHE WAS DOING FINE BY THE TIME OF THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328841 OMNIPOD INSULIN PUMP PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization