BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 22901828 · Received August 27, 2025

    Report

    Report Number
    3004464228-2025-38333
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    July 28, 2025
    Report Date
    August 27, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER CASE REVIEW ON 27-AUG-2025, B5 HAS BEEN UPDATED, AND THIS CASE IS NOT REPORTABLE. PLEASE DISREGARD REPORT # 3004464228-2025-38333-00 AS IT WAS REPORTED IN ERROR.

    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 OR DETERMINE THE ROOT CAUSE OF THE REPORTED DISLODGED CANNULA. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. LOCKED DOWN SMARTPHONE: PHONE_CONTROL_ANDROID, OMNIPOD SOFTWARE APP VERSION: 3.1.1, OPERATING SYSTEM: AP3A.240905.015.A2.S921USQS4BYF2, HARDWARE: SM-S921U, 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

    AFTER REVIEW OF THE CASE, IT WAS DETERMINED THAT THE POD FELL OFF WHILE THE PATIENT WAS ATTEMPTING TO PUT THE POD ON. IT WAS NOT REPORTED THAT THE CANNULA EVER EVEN INSERTED AND THEREFORE DISLODGED CANNULA IS NO LONGER BEING CONSIDERED AN EVENT.

    Description of Event or Problem · 0

    PATIENT STATED HIS BLOOD GLUCOSE ROSE TO ABOVE 250 MG/DL. WHILE PLACING THE POD ON HIS ABDOMEN, THE ADHESIVE SEPARATED COMPLETELY FROM THE SKIN, AND THE POD WAS WORN FOR LESS THAN ONE HOUR. FOR TREATMENT, THE PATIENT APPLIED A NEW POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467698 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 PH1U08092411 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male