BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 19163000 · Received April 23, 2024

    Report

    Report Number
    3004464228-2024-14417
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    April 17, 2024
    Report Date
    April 23, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    10385082000146
    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 HAS BEEN INITIATED BY INSULET CORPORATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT THE OMNIPOD PERSONAL DIABETES MANAGER (PDM) BATTERY BEGAN LEAKING AND SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941852 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION PT-000011 L000278 10385082000146

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown