BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 23657924 · Received November 26, 2025

    Report

    Report Number
    3004464228-2025-59136
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 1, 2025
    Report Date
    November 26, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000579
    PMA / PMN Number
    K231826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. 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 CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY. LOCKED DOWN SMARTPHONE: PHONE_CONTROL_ANDROID. OMNIPOD SOFTWARE APP VERSION: 3.1.1. OPERATING SYSTEM: TP1A.220624. 014.N981USQSEHYH1. HARDWARE: SM-N981U. 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

    IT WAS REPORTED BY THE PATIENT THAT THE PINK SLIDE DID NOT MOVED FORWARD, IS NOT VISIBLE IN THE VIEWING WINDOW AND WHEN THE POD WAS REMOVED THE CANNULA WAS NOT VISIBLE. NO IMPACT TO THE PATIENT'S GLUCOSE LEVEL WAS REPORTED. THE POD WAS WORN LESS THAN AN HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2030299 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 PH1U02152531 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female