BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 23042857 · Received September 12, 2025

    Report

    Report Number
    3004464228-2025-41730
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    June 4, 2025
    Report Date
    September 25, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000138
    PMA / PMN Number
    K203768
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DISREGARD MDR REPORT REFERENCE #3004464228-2025-41730-00, PER CORRECTION AFTER INTERNAL REVIEW, THERE WAS NO INDICATION OF A NEEDLE MECHANISM FAILURE, THIS IS NOT REPORTABLE.

    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: LOCKDOWN. OMNIPOD SOFTWARE APP VERSION: 3.1.2-P001. OPERATING SYSTEM: N5004L-AM-Q-MV01602-06-01.06. HARDWARE: N5004L. 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

    NOT APPLICABLE AS THE EVENT IS NOT REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CANNULA INSERTED INTO THE SKIN, BUT THE PINK SLIDE DID NOT MOVE FORWARD, INDICATING A NEEDLE MECHANISM FAILURE. THE PATIENT RECEIVED A MESSAGE TO CHANGE THE POD. THEY ALSO REPORTED "THE POD WAS NOT INJECTING INSULIN TO THE BODY." THE CANNULA WAS NOT VISIBLE WHEN THE POD WAS REMOVED. THE POD WAS WORN BETWEEN 25 AND 36 HOURS ON AN UNSPECIFIED SITE AND NO CHANGE TO BLOOD GLUCOSE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2070575 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000438 PH1U11152431 10385083000138

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female