BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 21412039 · Received February 19, 2025

    Report

    Report Number
    3004464228-2025-07104
    Event Type
    Malfunction
    Date Received
    February 19, 2025
    Date of Event
    January 22, 2025
    Report Date
    March 12, 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

    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. *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. CLOUD - LOCKED DOWN/SMARTPHONE LOCKDOWN CLOUD - OMNIPOD 5 SOFTWARE APP VERSION 3.1.1 CLOUD - SMARTPHONE OPERATING SYSTEM N5004L-AM-Q-MV01602-06-01.06 CLOUD - SMARTPHONE HARDWARE N5004L CLOUD - CGM SENSOR TYPE G7.

    Additional Manufacturer Narrative · 0

    THE RETURNED DEVICE WAS EVALUATED AND THE DEVICE WAS RECEIVED NOT DEPLOYED. DATA INDICATES THE DEVICE WAS DEACTIVATED AFTER THE COMPLETION OF FIRST PRIME, PRIOR TO WHEN THE DEVICE IS INTENDED TO DEPLOY. NO DAMAGES OR DEFECTS THAT WOULD CONTRIBUTE TO A NEEDLE MECHANISM FAILURE WERE OBSERVED. THE DEVICE OPERATED AS INTENDED.

    Description of Event or Problem · 0

    A PATIENT REPORTS WHILE WEARING A POD FOR LESS THAN AN HOUR THE CANNULA HAD FAILED TO DEPLOY AND THE PODS PINK SLIDE HAD NOT MVOED FORWARD AT INITIAL ACTIVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2572418 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 PH1M06252411 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male