BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 PDM CONTROLLER

    MDR report key: 17407133 · Received July 25, 2023

    Report

    Report Number
    MW5120187
    Event Type
    Malfunction
    Date Received
    July 25, 2023
    Date of Event
    July 17, 2023
    Report Date
    July 21, 2023
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000022
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE OMNIPOD 5 CONTROLLER OVERHEATED WHILE CHARGING AND THE BACK PART OF THE CONTROLLER STARTED SWELLING AND GOT REALLY HOT. REF: PDM-H001-G-XX, LOT: H000467, MFG: 2022-06-24, SN: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467331 OMNIPOD 5 PDM CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION OMNIPOD 5 CONTROLLER H000467 10385083000022

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male Other BAQSIMI.| DEXCOM G6.| OMNIPOD 5.| U100 INSULIN.