BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD DASH INSULIN MANAGEMENT SYSTEM

    MDR report key: 17950427 · Received October 17, 2023

    Report

    Report Number
    3004464228-2023-28935
    Event Type
    Malfunction
    Date Received
    October 17, 2023
    Date of Event
    September 19, 2023
    Report Date
    September 20, 2023
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO D(1): BRAND NAME CHANGED FROM OMNIPOD 5 POD TO OMNIPOD DASH INSULIN MANAGEMENT SYSTEM CORRECTION TO D(2A): COMMON DEVICE NAME FROM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP TO PUMP, INFUSION, INSULIN CORRECTION TO D(2B): PROCODE FROM QFG TO LZG.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENT THAT THE POD'S PINK SLIDE DID NOT MOVE FORWARD INDICATING A NEEDLE MECHANISM FAILURE. THE BLOOD GLUCOSE LEVELS 380 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077583 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18325 PD1U06162221 20385082000051
    985782 OMNIPOD DASH INSULIN MANAGEMENT SYSTEM PUMP, INFUSION, INSULIN LZG INSULET CORPORATION 18325 PD1U06162221 20385082000051

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male