BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 23327637 · Received October 17, 2025

    Report

    Report Number
    3004464228-2025-48911
    Event Type
    Malfunction
    Date Received
    October 17, 2025
    Date of Event
    August 27, 2025
    Report Date
    October 17, 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. 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 DISLODGED CANNULA. LOCKED DOWN SMARTPHONE: LOCKDOWN OMNIPOD SOFTWARE APP VERSION: 3.1.1 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 PATIENT'S BLOOD GLUCOSE LEVELS WERE GREATER THAN 250 MG/DL WHILE WEARING THE POD BETWEEN 24 AND 36 HOURS. THE PATIENT WAS PLAYING ON THE PLAYGROUND AND GOT HIT AND THE CANNULA CAME OUT. IT IS UNCLEAR IF THE POD ITSELF WAS HIT. THE ADHESIVE COMPLETELY SEPARATED FROM THE INFUSION SITE (LEG), CAUSING THE CANNULA TO DISLODGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322826 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 PH1M02062511 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male