BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 23264170 · Received October 10, 2025

    Report

    Report Number
    3004464228-2025-47334
    Event Type
    Injury
    Date Received
    October 10, 2025
    Date of Event
    September 30, 2025
    Report Date
    October 10, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    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 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. LOCKED DOWN SMARTPHONE: LOCKDOWN OMNIPOD SOFTWARE APP VERSION: 3.1.2-P001 OPERATING SYSTEM: N5004L-AM-Q-MV01602-06-01.06 HARDWARE: N5004L CGM SENSOR TYPE: G6. PLEASE NOTE, THE DEVICE IDENTIFIERS ARE CAPTURED AS REPORTED BY THE COMPLAINANT AND MAY NOT ALIGN WITH THE DEVICE CONFIGURATION REPORTED IN THIS SECTION AS THIS DATA IS PULLED FROM OUR CLOUD BASED ON THE REPORTED DATE OF EVENT.

    Description of Event or Problem · 0

    ON THE EVENING OF (B)(6) THE PATIENT'S ACETONE LEVEL WAS MEASURED AT 1.7. THE POD WAS THEN CHANGED TO THE ABDOMEN, AS THE PATIENT CONTINUES TO INJECT IN THE THIGHS. THE FOLLOWING MORNING, AROUND 6 AM, THE ACETONE LEVEL INCREASED TO 2.7. THE PATIENT WAS TRANSFERRED TO THE PEDIATRIC DEPARTMENT ON (B)(6). BLOOD GLUCOSE READINGS WERE >400 MG/DL AND 377 MG/DL PRIOR TO THE INCIDENT, AND 390 MG/DL AND 330 MG/DL AFTERWARD. THE POD AS WORN ON THE ABDOMEN FOR A DURATION BETWEEN 49 AND 71 HOURS. TREATMENT INCLUDED INSULIN ADMINISTERED VIA PSE (FOR A DTQ UNDER OP5 PROTOCOL AT 22.20 UI TOTAL DAILY DOSE, WITH 14 UI BASAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1936879 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-001193 8479

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown