BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 12639171 · Received October 15, 2021

    Report

    Report Number
    3004464228-2021-18580
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Date of Event
    October 14, 2021
    Report Date
    October 14, 2021
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED NOT DEPLOYED. THE DOWNLOAD DATA SHOWS THAT THE POD WAS IN POD STATE 1, INDICATING THAT THE DEVICE WAS NEVER FILLED. ALL DRIVE MECHANISM COMPONENTS WERE CLOSELY INSPECTED AND NO DAMAGES OR DEFECTS WERE FOUND THAT WOULD RESULT IN THE DEVICE NOT DEPLOYING.

    Additional Manufacturer Narrative · 0

    ADD TO TYPE OF INVESTIGATION : B01 TESTING OF ACTUAL/SUSPECTED DEVICE.

    Additional Manufacturer Narrative · 0

    ADD TO INVESTIGATION FINDINGS = C19 NO DEVICE PROBLEM FOUND. ADD TO INVESTIGATION CONCLUSIONS = D14 NO PROBLEM DETECTED.

    Additional Manufacturer Narrative · 1

    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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FOUND CANNULA HAD NOT DEPLOYED AS INTENDED. THE CANNULA WAS NOT VISIBLE AND THE PINK SLIDE DID NOT MOVE FORWARD, INDICATING A NEEDLE MECHANISM FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1540790 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18320 PD1C11282051 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female