BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 15411801 · Received September 13, 2022

    Report

    Report Number
    3004464228-2022-16817
    Event Type
    Injury
    Date Received
    September 13, 2022
    Date of Event
    September 1, 2022
    Report Date
    September 2, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120057
    PMA / PMN Number
    K192659
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND DIABETIC KETOACIDOSIS. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.

    Additional Manufacturer Narrative · 0

    CORRECTION TO D(4): CATALOG NO CHANGED FROM UNAVAILABLE TO ZXP425. CORRECTION TO G(5): PMA/510(K) # CHANGED FROM UNAVAILABLE TO K192659.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 566 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. SYMPTOMS REPORTED INCLUDE HYPERGLYCEMIA, VOMITING, PAIN, AND LETHARGY. AS TREATMENT, THE PATIENT ADMINISTERED INSULIN CORRECTIONS AND PER THE ADVICE OF THEIR DOCTOR APPLIED A NEW POD. ONCE AT THE HOSPITAL THE PATIENT HAD BLOOD WORK ADMINISTERED AS WELL AS AN INSULIN DRIP AND INTRAVENOUS FLUIDS. THE PATIENT WAS TRANSPORTED TO A PEDIATRIC HOSPITAL WHERE THEY WERE ADMITTED. THE PATIENT WAS IN BOTH HOSPITALS FOR A TOTAL OF 29 HOURS BEFORE BEING RELEASED. THE PATIENT WAS PRESCRIBED INSULIN AS WELL AS PENS. THE PATIENT WILL BE FOLLOWING UP WITH THEIR ENDOCRINOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2533887 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18025 L71356 20385081120057

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male Hospitalization