BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 16137836 · Received January 11, 2023

    Report

    Report Number
    3004464228-2023-00958
    Event Type
    Malfunction
    Date Received
    January 11, 2023
    Date of Event
    December 20, 2022
    Report Date
    December 20, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    10385082000009
    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 HAS BEEN INITIATED BY INSULET CORPORATION. THE COMPLAINT REPORTED THERMAL ISSUE IS CURRENTLY UNDER THE REFERENCED CAPA INVESTIGATION. NO FURTHER POST MARKET LAB INVESTIGATION EVALUATION IS REQUIRED. CORRECTION TO D(4): SEQUENCE NUMBER CHANGED FROM UNAVAILABLE TO 010302-03601.

    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. THE COMPLAINT REPORTED THERMAL ISSUE IS CURRENTLY UNDER THE REFERENCED CAPA INVESTIGATION. NO FURTHER POST MARKET LAB INVESTIGATION EVALUATION IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT THE OMNIPOD PERSONAL DIABETES MANAGER (PDM) IS OVERHEATING WHEN NOT ON THE CHARGER. IT WAS ALSO MENTIONED THAT THE PDM IS NOT HOLDING A CHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908897 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18239 L000398 10385082000009

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female