BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM

    MDR report key: 16246307 · Received January 26, 2023

    Report

    Report Number
    3004464228-2023-02195
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    January 9, 2023
    Report Date
    January 9, 2023
    Manufacturer
    INSULET CORPORATION
    Product Code
    LZG
    UDI-DI
    20385081120033
    PMA / PMN Number
    K162296
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM OR DETERMINED THE NEEDLE MECHANISM FAILURE REPORTED. 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.

    Additional Manufacturer Narrative · 0

    D4 - CATALOG NO: CHANGED FROM BLE-I1-529 TO ZXP4525; MODEL NO CHANGED FROM: 18320 TO 19191 UNIQUE IDENTIFIER (IUD) CHANGED FROM (B)(4) TO(B)(4) . G5- PMA/510K# CHANGED FROM K192659 TO K162296

    Description of Event or Problem · 0

    IT WAS REPORTED THE CANNULA RETRACTED, INDICATING A NEEDLE MECHANISM FAILURE. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE NOT AFFECTED. THE POD WAS NOT WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823759 OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 19191 L72346 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female