BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 22112696 · Received May 30, 2025

    Report

    Report Number
    3004464228-2025-23260
    Event Type
    Malfunction
    Date Received
    May 30, 2025
    Date of Event
    May 26, 2025
    Report Date
    May 30, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K211575
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED ADVERSE EVENT AND HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS TREATED FOR HYPERGLYCEMIA AT A HEALTH CLINIC. THE PATIENT'S BLOOD GLUCOSE LEVEL REACHED 350 MG/DL. THE PATIENT'S POD BEGAN LEAKING INSULIN WHILE WEARING THE POD BETWEEN 25 AND 36 HOURS. THEY WERE ALSO DEALING WITH A VIRAL INFECTION AND A FEVER AT THE TIME OF THE REPORTED INCIDENT. AT THE HEALTH CLINIC, THEY WERE ADVISED TO WAIT 48 HOURS. DURING THAT TIME, THE FEVER PERSISTED, AND THE PATIENT BECAME DEHYDRATED AND EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS AND KETONES WERE ALSO PRESENT. THE CUSTOMER'S MOTHER TOOK THEM BACK TO THE HEALTH CLINIC, WHERE THEY WERE TREATED WITH INTRAVENOUS FLUIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642877 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1K06062431 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization