BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 15510707 · Received September 30, 2022

    Report

    Report Number
    3004464228-2022-18151
    Event Type
    Injury
    Date Received
    September 30, 2022
    Date of Event
    September 24, 2022
    Report Date
    September 28, 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 HYPERGLYCEMIA. 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 WENT TO THE EMERGENCY ROOM (ER) AND WAS DIAGNOSED WITH BLOOD GLUCOSE (BG) VALUES THAT REACHED 430 MG/DL. FOR TREATMENT, THE PATIENT WAS ADMINISTERED INTRAVENOUS (IV) SALINE. THE POD WAS WORN BETWEEN 4 AND 24 HOURS ON THE ARM. THE PATIENT WAS DISCHARGED AFTER 4 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1748318 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18025 L71356 20385081120057

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female Required Intervention| H