BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 CONTROLLER

    MDR report key: 24159869 · Received January 23, 2026

    Report

    Report Number
    3014585508-2026-03265
    Event Type
    Malfunction
    Date Received
    January 23, 2026
    Date of Event
    January 9, 2026
    Report Date
    January 23, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000022
    PMA / PMN Number
    K203768
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED THERMAL DEVICE MALFUNCTION IS ASSOCIATED WITH A PERSONAL DIABETES MANAGER MANUFACTURED AFTER THE CORRECTION FOR ACTION RES#(B)(4) WAS IMPLEMENTED. ACCORDING TO THE COMPLAINANT, THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE CAUSE OF THE REPORTED EVENT. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. 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 FATHER REPORTED THAT THE OP5 PERSONAL DIABETES MANAGER (PDM) FOR HIS DAUGHTER HAD CHARGING ISSUES FOR TWO DAYS. THIS INCLUDED INTERMITTENT CHARGING, HEAT DURING CHARGING, AND A BURNT SMELL AT THE CHARGING PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222424 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000409 H000518 10385083000022

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Female