BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 22175222 · Received June 10, 2025

    Report

    Report Number
    3004464228-2025-25378
    Event Type
    Injury
    Date Received
    June 10, 2025
    Date of Event
    June 5, 2025
    Report Date
    June 10, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000138
    PMA / PMN Number
    K203768
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED EMERGENCY ROOM VISIT 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. CLOUD - LOCKED DOWN/SMARTPHONE DATA NOT AVAILABLE CLOUD - OMNIPOD 5 SOFTWARE APP VERSION DATA NOT AVAILABLE. CLOUD - SMARTPHONE OPERATING SYSTEM DATA NOT AVAILABLE. CLOUD - SMARTPHONE HARDWARE DATA NOT AVAILABLE. CLOUD - CGM SENSOR TYPE DATA NOT AVAILABLE. PLEASE NOTE, THAT SECTION D IS CAPTURING THE DEVICE IDENTIFIERS AS REPORTED BY THE COMPLAINANT. THIS MAY NOT ALIGN TO THE DEVICE CONFIGURATION REPORTED IN H11, AS THIS DATA IS PULLED FROM OUR CLOUD BASED ON THE REPORTED DATE OF EVENT.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THEIR BLOOD GLUCOSE (BG) LEVELS ROSE TO 445 MG/DL WHILE WEARING THE POD ON THE ARM FOR BETWEEN 5 AND 24 HOURS. KETONE LEVELS INCREASED (LEVELS NOT PROVIDED) AND THE PATIENT DRANK A LOT OF WATER. PATIENT REMOVED THE POD AND VISITED THE EMERGENCY ROOM ZENTRALE NOTAUFNAHME LOCATED IN DRK KLINIKEN BERLIN MITTE. A DIABETES CONSULTANT SET UP A NEW POD WITH INSULIN FOR THE PATIENT. THE PATIENT WAS RELEASED AFTER 4 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266082 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000438 PH1U01072521 10385083000138

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Hospitalization