BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 23727164 · Received December 5, 2025

    Report

    Report Number
    3004464228-2025-60704
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    November 23, 2025
    Report Date
    December 8, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000548
    PMA / PMN Number
    K231826
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE DISREGARD REF REPORT 3004464228-2025-60704-00. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NOT A NEEDLE MECHANISM FAILURE THEREFORE NO REGULATORY REPORT IS NEEDED.

    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. 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 DETACHED / BROKE-OFF CANNULA. LOCKED DOWN SMARTPHONE: LOCKDOWN OMNIPOD SOFTWARE APP VERSION: 3.1.5-P001 OPERATING SYSTEM: N5004L-AM-Q-MV01602-06-01.06 HARDWARE: N5004L CGM SENSOR TYPE: G7 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 THAT THE POD'S CANNULA DETACHED PRIOR TO ACTIVATION, RESULTING IN THE CANNULA BREAKING OFF. THE POD WAS NOT WORN. NO IMPACT ON THE PATIENT'S GLUCOSE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2855659 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM AUTOMATED INSULIN DELIVERY SYSTEM QFG INSULET CORPORATION PT-001446 PH1K02102551 20385083000548

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male