BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 20293440 · Received September 24, 2024

    Report

    Report Number
    3004464228-2024-38427
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    August 29, 2024
    Report Date
    September 24, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000213
    PMA / PMN Number
    K203768
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE IT WAS DISCARDED BY THE PATIENT. IT WAS REPORTED THAT THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL (BG) ROSE TO 400 MG/DL WHILE WEARING THE POD BETWEEN 5 AND 24 HOURS. THE POD REPORTEDLY FELL OFF THE INFUSION SITE (ARM) WHILE SWIMMING IN THE SEA, CAUSING THE CANNULA TO DISLODGE. AS TREATMENT, A NEW POD WAS PLACED. THE POD WAS LOST IN THE SEA AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1879038 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000536 PH1U01122411 10385083000213

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female