BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH, PDM, PERSONAL DIABETES MANAGER

    MDR report key: 20145155 · Received September 5, 2024

    Report

    Report Number
    3004464228-2024-35568
    Event Type
    Malfunction
    Date Received
    September 5, 2024
    Date of Event
    August 19, 2024
    Report Date
    September 5, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    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 HAS BEEN REPORTED THAT THE OMNIPOD PERSONAL DIABETES MANAGER (PDM) BATTERY IS SWELLING AND EMITTING HEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2073418 OMNIPOD DASH, PDM, PERSONAL DIABETES MANAGER PUMP, INFUSION, INSULIN LZG INSULET CORPORATION PT-000030 L000314

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male