BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 18392395 · Received December 26, 2023

    Report

    Report Number
    3004464228-2023-36546
    Event Type
    Malfunction
    Date Received
    December 26, 2023
    Date of Event
    November 24, 2023
    Report Date
    November 30, 2023
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    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

    CORRECTION TO D(1): FROM "OMNIPOD DASH INSULIN MANAGEMENT SYSTEM" TO "OMNIPOD 5 POD". CORRECTION TO D(2A): FROM "PUMP, INFUSION, INSULIN" TO "ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP". CORRECTION TO D(2B):FROM "LZG" TO "QFG".

    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 CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT THE POD'S CANNULA CAME OUT BEFORE BEING PLACED INDICATING A NEEDLE MECHANISM FAILURE. THE CANNULA WAS VISIBLE AND THE PINK SLIDE MOVED FORWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361362 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 PH1K01122311

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female