BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 21709212 · Received March 27, 2025

    Report

    Report Number
    3004464228-2025-13240
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    March 11, 2025
    Report Date
    March 28, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000579
    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

    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. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. CLOUD - LOCKED DOWN/SMARTPHONE PHONE_CONTROL_IOS. CLOUD - OMNIPOD 5 SOFTWARE APP VERSION 1.1.6. CLOUD - SMARTPHONE OPERATING SYSTEM 18.3. CLOUD - SMARTPHONE HARDWARE IPHONE14.3. CLOUD - 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.

    Additional Manufacturer Narrative · 0

    UPDATED D4 - MODEL # FROM PT-000435 TO PT-001662, UPDATED D4 - LOT # FROM UNAVAILABLE TO PH1U07202431, UPDATED D4 - CATALOG # FROM POD-BLE-H1-520 TO POD-OMNI-I1-6720, UPDATED D4 - SERIAL # (B)(6). UPDATED D4 - EXPIRATION DATE FROM UNAVAILABLE TO 1/20/2026. UPDATED D4 - PRIMARY UDI NUMBER FROM (B)(4). UPDATED H4 - DEVICE MFG DATE FROM UNAVAILABLE TO 7/20/2024.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE DEPLOYED PRIOR TO PROPER POD ACTIVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2658323 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-001662 PH1U07202431 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown