BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 19815303 · Received July 24, 2024

    Report

    Report Number
    3004464228-2024-28135
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    July 12, 2024
    Report Date
    July 24, 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
    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 BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED 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 CONFIRMING THE BLUE SOFT CANNULA IS INSPECTED FOR ANY DAMAGE.

    Additional Manufacturer Narrative · 0

    CORRECTION TO H6: HEALTH EFFECT - CLINICAL CODE ADDED E171601.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE LEVEL ROSE TO OVER 300 MG/DL WHILE WEARING THE POD BETWEEN 36 AND 48 HOURS. WHEN REMOVED FROM THE INFUSION SITE (ARM), THE POD'S CANNULA WAS FOUND BENT. IT WAS ALSO REPORTED THAT THE POD WAS LEAKING INSULIN AND THE SITE HAD A RED MARK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2370483 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 PH1U09252311 10385083000114

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female