BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 20759867 · Received November 22, 2024

    Report

    Report Number
    3004464228-2024-47749
    Event Type
    Malfunction
    Date Received
    November 22, 2024
    Date of Event
    November 6, 2024
    Report Date
    November 22, 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. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    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 WHILE WALKING THE PODS ADHESIVE HAD SEPARATED FROM THE POD INFUSION SITE (HI[P/BUTTOCKS), CAUSING THE CANNULA TO BECOME DISLODGED. AS TREATMENT, THE PATIENT APPLIED A NEW POD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1797927 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 10385083000114

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female