BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 16022952 · Received December 21, 2022

    Report

    Report Number
    3004464228-2022-24186
    Event Type
    Malfunction
    Date Received
    December 21, 2022
    Date of Event
    October 26, 2022
    Report Date
    December 16, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K192659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    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 CAUGHT FIRE AND WAS EXTINGUISHED WITH WATER . THE PDM BATTERY WAS BEING CHARGED WHEN THE INCIDENT OCCURRED. THE PATIENT NOTED A PIECE OF FABRIC WAS PLACED NEAR THE PDM AT THE TIME OF INCIDENT. THE BATTERY SWELLED AND DISLODGED FROM THE PDM. NO ALLEGATIONS OF INJURIES WERE EXPERIENCED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477251 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION PT-000010 L000291

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown