BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 21094496 · Received January 7, 2025

    Report

    Report Number
    3004464228-2025-01043
    Event Type
    Injury
    Date Received
    January 7, 2025
    Date of Event
    December 11, 2024
    Report Date
    January 23, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000051
    PMA / PMN Number
    K211575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE HOSPITALIZATION WAS NOT RELATED TO THE PUMP LEAKING; THEREFORE THIS WAS NOT A REPORTABLE DEVICE MALFUNCTION. THE MEDICAL EVENT HAS BEEN REPORTED UNDER EMDR-233756. H6 REMOVED LOSS OF CONSCIOUSNESS AND REPLACED WITH E2403, HOSPITALIZATION REMOVED AND REPLACED WITH NO HEALTH CONSEQUENCES OR IMPACT, INSUFFICIENT INFORMATION REMOVED AND REPLACED WITH FLUID LEAK.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND LOW BLOOD GLUCOSE LEVELS. 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 HAD BEEN HOSPITALIZED WITH LOW BLOOD GLUCOSE LEVELS. THE PATIENT REPORTS THE POD WAS LEAKING INSULIN. THE PATIENT REPORTS THE POD WAS CLICKING AND KEPT DELIVERING INSULIN. THE PATIENT REPORTS THEY HAD LOST CONSCIOUSNESS. ONCE AT THE HOSPITAL EMERGENCY ROOM THE PATIENT REPORTS HAVING THE INSULIN FLUSHED. THE PATIENT REPORTS THEY WERE DISCHARGED FROM THE HOSPITAL THE SAME DAY. THE PATIENT REPORTS HAVING PLACED A NEW POD ON ONCE AT HOME FROM THE HOSPITAL THAT WAS MAKING CLICKING SOUNDS AS WELL AS 4 OTHERS THAT HAVE BEEN REPORTED. THE PATIENT OPENED A NEW BOX OF PODS AND WAS ABLE TO APPLY A NEW POD WITH SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869151 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18325 PD1U11112311 20385082000051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization