BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 24333088 · Received February 13, 2026

    Report

    Report Number
    3014585508-2026-07336
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    December 21, 2025
    Report Date
    February 13, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K211575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 CONFIRM OR DETERMINE THE ROOT CAUSE OF THE REPORTED DISLODGED CANNULA. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO 300 MG/DL WHILE WEARING THE POD BETWEEN 25 AND 36 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (ABDOMEN) WHEN THE PATIENT WAS SWEATING, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS APPLIED. CASE 2 OF 4 (RELATED CASES: CN-6092282, CN-6092284 AND CN-6092285).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395438 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1K03282411 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Female