BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 21998435 · Received May 9, 2025

    Report

    Report Number
    3004464228-2025-20411
    Event Type
    Malfunction
    Date Received
    May 9, 2025
    Date of Event
    April 19, 2025
    Report Date
    June 1, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED NOT DEPLOYED. THE DOWNLOAD DATA SHOWS THAT THE DEVICE COMPLETED 49 PULSES AND WAS DEACTIVATED BY THE USER AT THE END OF THE FIRST PRIMING SEQUENCE. SINCE THE USER DEACTIVATED THE DEVICE BEFORE THE START OF THE SECOND PRIMING SEQUENCE, THE NEEDLE NEVER DEPLOYED. THE NEEDLE MECHANISM DEPLOYED SUCCESSFULLY UPON MANUAL ROTATION OF THE RATCHET GEAR. NO DAMAGES OR DEFECTS WERE OBSERVED THAT WOULD RESULT IN THE NEEDLE FAILING TO DEPLOY BY THE END OF THE SECOND PRIMING SEQUENCE.

    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 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: LOCKDOWN OMNIPOD SOFTWARE APP VERSION: 3.1.1 SMARTPHONE OPERATING SYSTEM: N5004L-AM-Q-MV01602-06-01.06 SMARTPHONE HARDWARE: N5004L CGM SENSOR TYPE: G6 *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 (B)(6) 2025, THE PINK SLIDE INSERT DID NOT MOVE INTO THE VIEWING WINDOW, INDICATING A FAILURE OF THE NEEDLE MECHANISM TO DEPLOY AS INTENDED DURING ACTIVATION. IT SHOULD BE NOTED THAT THE LOT DETAILS PROVIDED SHOW THIS POD EXPIRED 15 MAR 2025, AND THEREFORE THE PATIENT ATTEMPTED TO ACTIVATE AN EXPIRED POD. THE POD WAS NOT WORN AND NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1882057 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000536 PH1K09152341 10385083000213

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male