BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 23050393 · Received September 15, 2025

    Report

    Report Number
    3004464228-2025-41852
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    August 15, 2025
    Report Date
    September 15, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K211575
    Product Problem
    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. 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 383 MG/DL WHILE WEARING THE POD BETWEEN 5 AND 24 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (LEG) WHILE THE PATIENT WAS AT A PLAYGROUND, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS SUCCESSFULLY APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1952120 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1U11132421 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male