BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 20279229 · Received September 23, 2024

    Report

    Report Number
    3004464228-2024-38099
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    January 6, 2024
    Report Date
    September 23, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385082000051
    PMA / PMN Number
    K211575
    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 CONFIRMING THAT THE DEVICE DEPLOYED THE CANNULA CORRECTLY. THE LOT DETAILS PROVIDED SHOW THAT THE PATIENT WAS USING AN EXPIRED POD. AS PER OMNIPOD DASH® INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE (MODEL: PDM-INT2-D001-MM PT-000002-GBR-ENG-MM-AW REV. 004 11/20, 3 CHANGING YOUR POD / PAGE 40) WARNINGS: DO NOT USE A POD IF IT IS PAST THE EXPIRY DATE ON THE PACKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT FOUND NEEDLE HAD NOT DEPLOYED AS INTENDED. THE CANNULA WAS NOT VISIBLE, INDICATING A NEEDLE MECHANISM FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1450029 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18325 PD1U06212211 20385082000051

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male