BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 21656734 · Received March 20, 2025

    Report

    Report Number
    3004464228-2025-12205
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Date of Event
    February 24, 2025
    Report Date
    March 20, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000579
    PMA / PMN Number
    K231826
    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. 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 COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. CLOUD - LOCKED DOWN/SMARTPHONE PHONE_CONTROL_ANDROID CLOUD - OMNIPOD 5 SOFTWARE APP VERSION 3.1.1 CLOUD - SMARTPHONE OPERATING SYSTEM TP1A.220624. 014.G781VSQSIHXL2 CLOUD - SMARTPHONE HARDWARE SM-G781V CLOUD - CGM SENSOR TYPE G6 *PLEASE NOTE, THAT SECTION D IS CAPTURING THE DEVICE IDENTIFIERS AS REPORTED BY THE COMPLAINANT. THIS MAY NOT ALIGN TO THE DEVICE CONFIGURATION REPORTED IN H11, AS THIS DATA IS PULLED FROM OUR CLOUD BASED ON THE REPORTED DATE OF EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CANNULA DEPLOYED AT POD ACTIVATION, BUT THE PATIENT STATED "THE NEEDLE NEVER CAME DOWN FROM THE MECHANISM" AND THE CANNULA DID NOT PROPERLY INSERT INTO THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1332009 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 PH1U07122411 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female