BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 CONTROLLER

    MDR report key: 21000136 · Received December 23, 2024

    Report

    Report Number
    3004464228-2024-51193
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    November 27, 2024
    Report Date
    December 23, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    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. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED UNABLE TO PAUSE INSULIN DELIVERY REPORTED. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. PER OMNIPOD 5 USER GUIDE REFERENCE #: PDM-H001-G-MG PT-002111-AW REV. 02 10/24, PAGE 15 "CAUTION: ALWAYS CHECK YOUR GLUCOSE FREQUENTLY DURING AMUSEMENT PARK RIDES AND FLYING OR OTHER SITUATIONS WHERE SUDDEN CHANGES OR EXTREMES OF AIR PRESSURE, ALTITUDE, OR GRAVITY MAY BE OCCURRING. THOUGH THE OMNIPOD 5 SYSTEM IS SAFE TO USE AT ATMOSPHERIC PRESSURES TYPICALLY FOUND IN AIRPLANE CABINS DURING FLIGHT, THE ATMOSPHERE PRESSURE IN AN AIRPLANE CABIN CAN CHANGE DURING FLIGHT, WHICH MAY AFFECT THE POD'S INSULIN DELIVERY. RAPID CHANGES IN ALTITUDE AND GRAVITY, SUCH AS THOSE TYPICALLY FOUND ON AMUSEMENT PARK RIDES OR FLIGHT TAKE-OFF AND LANDING, CAN AFFECT INSULIN DELIVERY, LEADING TO POSSIBLE HYPOGLYCEMIA OR INJURY. IF NEEDED, FOLLOW YOUR HEALTHCARE PROVIDER'S TREATMENT INSTRUCTIONS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO PAUSE INSULIN DELIVERY. THE PATIENT REPORTED THEIR OMNIPOD SYSTEM RELEASES INSULIN WITHOUT WARNING WHEN THEY ARE IN AN AIRPLANE OR MOUNTAINS WITH CHANGES IN ALTITUDE. PATIENT REPORTED PAUSING THE INSULIN DELIVERY DOES NOT PREVENT INSULIN FROM BEING DELIVERED. NO IMPACT ON BLOOD GLUCOSE LEVELS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2626047 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000409

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female