BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULET OMNIPOD 5

    MDR report key: 24821043 · Received April 8, 2026

    Report

    Report Number
    MW5186476
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    April 2, 2026
    Report Date
    April 3, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AN 8-YEAR-OLD WITH KNOWN TYPE 1 DIABETES WAS USING AN OMNIPOD 5 CSII SYSTEM THAT FAILED TO DELIVER INSULIN TO THE PATIENT, WHICH CAUSED PATIENT TO GO INTO DKA AND BE HOSPITALIZED IN A PEDIATRIC ICU FOR A PERIOD OF 24 HOURS. WITH STANDARD DKA THERAPY THE PATIENTS DKA RESOLVED. PATIENT'S MOTHER HAS DECIDED TO SWITCH BACK TO MULTIPLE DAILY INJECTIONS OF INSULIN GIVEN FAILURE OF THE OMNIPOD 5 CSII SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21857 INSULET OMNIPOD 5 ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION POD-OMNI-I1-6720 PH1U10162531

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male Required Intervention| L| H NOVOLOG: (B)(6).