BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 21986852 · Received May 8, 2025

    Report

    Report Number
    3004464228-2025-20032
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    April 10, 2025
    Report Date
    May 8, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000213
    PMA / PMN Number
    K203768
    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. 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 COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. THE LOT DETAILS PROVIDED SHOW THAT THE PATIENT WAS USING AN EXPIRED POD. AS PER OMNIPOD®5 AUTOMATED INSULIN DELIVERY SYSTEM - USER GUIDE (MODEL: PDM-H001-G-XX PT-000369-AW REV 009 08/22, 5 ACTIVATING AND CHANGING YOUR POD / PAGE 95) CAUTION: DO NOT USE A PF10OD IF THE STERILE PACKAGING IS OPEN OR DAMAGED, THE POD HAS BEEN DROPPED AFTER REMOVAL FROM THE PACKAGE, OR THE POD IS EXPIRED AS THE POD MAY NOT WORK PROPERLY AND INCREASE YOUR RISK OF INFECTION. LOCKED DOWN SMARTPHONE: PHONE_CONTROL_ANDROID OMNIPOD SOFTWARE APP VERSION: 3.1.1 SMARTPHONE OPERATING SYSTEM: UP1A.231005.007.S911USQS6CYB3 SMARTPHONE HARDWARE: SM-S911U CGM SENSOR TYPE: G7 *PLEASE NOTE, THAT SECTION D IS CAPTURING THE DEVICE IDENTIFIERS AS REPORTED BY THE COMPLAINANT. THIS MAY NOT ALIGN TO THE DEVICE CONFIGURATION REPORTED IN H11, AS THIS DATA IS PULLED FROM OUR CLOUD BASED ON THE REPORTED DATE OF EVENT.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT ON 10 APR 2025, THE PINK SLIDE INSERT MOVED INTO THE VIEWING WINDOW, INDICATING THE NEEDLE MECHANISM DEPLOYED AS INTENDED DURING ACTIVATION. HOWEVER, THEY REPORTED THE CANNULA DID NOT DEPLOY AND WAS NOT VISIBLE WHEN THE POD WAS REMOVED. IT SHOULD BE NOTED THAT THE LOT DETAILS PROVIDED SHOW THIS POD EXPIRED 16 SEP 2024, AND THEREFORE THE PATIENT ATTEMPTED TO ACTIVATE AN EXPIRED POD. NO PATIENT CONSEQUENCES WERE REPORTED AND THE POD WAS NOT WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998049 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000536 PH1K03162341 10385083000213

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male