BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 16087271 · Received January 3, 2023

    Report

    Report Number
    3004464228-2023-00102
    Event Type
    Malfunction
    Date Received
    January 3, 2023
    Date of Event
    December 20, 2022
    Report Date
    December 20, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    10385082000146
    PMA / PMN Number
    K192659
    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 THAT THE OMNIPOD PERSONAL DIABETES MANAGER (PDM) BATTERY WAS SWELLING. NO ADVERSE PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209690 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION PT-000011 L000308 10385082000146

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown