BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 16366612 · Received February 13, 2023

    Report

    Report Number
    3004464228-2023-04461
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    February 10, 2023
    Report Date
    February 10, 2023
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385082000020
    PMA / PMN Number
    K19259
    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 - MODEL NO: CHANGED FROM PT-000435 TO 18320 ; D4 - CATALOG NO CHANGED FROM POD-BLE-H1-520 TO BLE-I1-529; D4 - UNIQUE IDENTIFIER (UDI) # CHANGED FROM (B)(4). TO(B)(4). G4: CHANGED FROM PMA/510(K) # K203768 TO K19259.

    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
    1388276 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION 18320 PD1U12232131 20385082000020

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female