BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 14670381 · Received June 11, 2022

    Report

    Report Number
    3004464228-2022-09443
    Event Type
    Malfunction
    Date Received
    June 11, 2022
    Date of Event
    June 6, 2022
    Report Date
    June 7, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K192659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR TO DETERMINE ITS ROOT CAUSE. 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. FOR: OMNI POD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE MODEL: LZG 18296-ENG-AW REV B CHANGING YOUR POD CHAPTER 3 / PAGE 40 WARNINGS: DO NOT USE A POD IF IT IS PAST THE EXPIRATION DATE ON THE PACKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE DEPLOYED EARLY WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS NOT WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2685146 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PS1K10212021 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male