BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 19916147 · Received August 6, 2024

    Report

    Report Number
    3004464228-2024-30379
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    August 2, 2024
    Report Date
    August 6, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    10385082000139
    PMA / PMN Number
    K211575
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A TECHNICAL ASSESSMENT OF THE DEVICE DESIGN IDENTIFIED THE ROOT CAUSE OF THE THERMAL EVENT TO BE THE DASH PDM CHARGING VOLTAGE EXCEEDING THE BATTERY SPECIFICATION, DEFINED AS OVERCHARGING. FIELD SAFETY CORRECTIVE ACTION 9056196-10/11/2022-001-C HAS BEEN INITIATED BY INSULET CORPORATION. THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635491 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION PT-000010 L000310 10385082000139

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male