BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 15104167 · Received July 26, 2022

    Report

    Report Number
    3004464228-2022-12920
    Event Type
    Malfunction
    Date Received
    July 26, 2022
    Date of Event
    July 18, 2022
    Report Date
    July 19, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000114
    PMA / PMN Number
    K203768
    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 THE REPORTED NEEDLE MECHANISM FAILURE OR 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 COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS.

    Additional Manufacturer Narrative · 0

    CORRECTION TO D2B - PROCODE CHANGED FROM UNAVAILABLE TO QFG. CORRECTION TO D(4): MODEL NO CHANGED FROM PT-000536 TO PT-000435.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CANNULA DID NOT DEPLOY WHEN THE POD WAS ACTIVATED; THIS INDICATES A NEEDLE MECHANISM FAILURE OCCURRED. THE POD WAS WORN LESS THAN ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340934 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 PP1K02072231 10385083000114

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male