BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 18118819 · Received November 13, 2023

    Report

    Report Number
    3004464228-2023-31849
    Event Type
    Malfunction
    Date Received
    November 13, 2023
    Date of Event
    October 15, 2023
    Report Date
    October 15, 2023
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED/RECEIVED TO DATE. IF THE DEVICE IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS. 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 P[INK SLIDE DID NOT MOVE FORWARD INDICATING A NEEDLE MECHANISM FAILURE. THE BLOOD GLUCOSE LEVELS ROSE TO 379 MG/DL WHILE WEARING THE POD FOR 1 AND 4 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2239775 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 PH1K08182211 10385083000114

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female