BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 19963806 · Received August 12, 2024

    Report

    Report Number
    3004464228-2024-31551
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    July 27, 2024
    Report Date
    August 12, 2024
    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

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. 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 ROSE TO OVER 250 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. IN ADDITION, THE PATIENT REPORTS THE PODS ADHESIVE HAD SEPARATED FROM THE POD INFUSION SITE (ABDOMEN), CAUSING THE CANNULA TO BECOME DISLODGED. AS TREATMENT, THE PATIENT APPLIED A NEW P OD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2028358 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 PH1K04182321 10385083000114

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male