BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24101855 · Received January 16, 2026

    Report

    Report Number
    3014585508-2026-02427
    Event Type
    Malfunction
    Date Received
    January 16, 2026
    Date of Event
    December 19, 2025
    Report Date
    May 21, 2026
    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

    PER ADDITIONAL INFORMATION RECEIVED ON APRIL 24, 2026, PLEASE DISREGARD REPORT #3014585508-2026-02427-00, AS THE PATIENT STATED THAT THE CANNULA WAS VISIBLE AND INTACT AFTER REMOVING THE POD, INDICATING NO NEEDLE MECHANISM FAILURE. THEREFORE, THE EVENT DOES NOT MEET REPORTING CRITERIA.

    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 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: 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

    THE PATIENT¿S BLOOD GLUCOSE LEVEL WAS REPORTED TO HAVE REACHED 18.6 MMOL/L (335 MG/DL) WHILE WEARING THE POD BETWEEN 37 AND 48 HOURS. AFTER NOTING ELEVATED BLOOD GLUCOSE LEVELS, THE PATIENT OBSERVED THAT THE CANNULA RETRACTED AND THE PINK SLIDE MOVED FORWARD; INDICATING A NEEDLE MECHANISM FAILURE. AS TREATMENT, THE PATIENT APPLIED A NEW POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400731 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM AUTOMATED INSULIN DELIVERY SYSTEM QFG INSULET CORPORATION PT-001446 PH1K12092431 20385083000548

    Patients

    Seq Age Sex Outcome Treatment
    1