BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24267463 · Received February 5, 2026

    Report

    Report Number
    3014585508-2026-05947
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    December 5, 2025
    Report Date
    February 12, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000548
    PMA / PMN Number
    K203768
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED D4 - MODEL # FROM PT-000438 TO PT-001446. UPDATED D4 - CATALOG # FROM POD-BLE-H1-529 TO POD-OMNI-I1-6720. UPDATED D4 - PRIMARY UDI NUMBER FROM (B)(4).

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. WE ARE UNABLE TO CONFIRM OR DETERMINE THE ROOT CAUSE OF THE REPORTED DISLODGED CANNULA.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO GREATER THAN 13.9 MMOL/L (250 MG/DL) WHILE WEARING THE POD BETWEEN 37 AND 48 HOURS. THE POD SEPARATED FROM THE ADHESIVE, LEAVING THE ADHESIVE AROUND THE INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331698 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-001446 PH1K01102521 20385083000548

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female