BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD INSULIN MANAGEMENT SYSTEM

    MDR report key: 16366552 · Received February 13, 2023

    Report

    Report Number
    3004464228-2023-04458
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    February 10, 2023
    Report Date
    February 10, 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. FOR: OMNI POD INSULIN MANAGEMENT SYSTEM USER GUIDE. MODEL: UST400. (B)(4) REV B 09/17. CHANGING YOUR POD . CHAPTER 3 PAGE 24 . WARNINGS: DO NOT USE A POD IF IT IS PAST THE EXPIRATION DATE ON THE PACKAGE.

    Additional Manufacturer Narrative · 0

    D4 CHANGED FROM D4 - MODEL NO: CHANGED FROM PT-000435 TO 14000; D4 - CATALOG NO CHANGED FROM POD-BLE-H1-520 TO ZXP425; D4 - UNIQUE IDENTIFIER (UDI) # CHANGED FROM (B)(4) TO (B)(4) .G4: CHANGED FROM PMA/510(K) # K203768 TO K162296.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE DID NOT MOVE FORWARD AND WHEN THE POD WAS ACTIVATED AND DID NOT RETRACT AS INTENDED; THIS INDICATES A NEEDLE MECHANISM FAILURE. THE POD WAS NOT WORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654747 OMNIPOD INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 14000 L42492 20385081120033

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female