BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 CONTROLLER

    MDR report key: 21104533 · Received January 8, 2025

    Report

    Report Number
    3004464228-2025-01252
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    February 2, 2023
    Report Date
    January 9, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000022
    PMA / PMN Number
    K203768
    Adverse Event
    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 DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED LOSS OF CONSCIOUSNESS. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS WAS A DUPLICATE EMDR REPORT SUBMITTED IN ERROR. THE ADVERSE EVENT REFERENCED IN EMDR 230975 WAS PREVIOUSLY REPORTED ON 4/21/2023 UNDER EMDR-134907.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD TO SEEK MEDICAL ATTENTION DUE TO PASSING OUT AND CLIMBING BLOOD GLUCOSE LEVELS. THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED AN UNKNOWN LEVEL. ACCORDING TO THE PATIENT THEY BROKE THEIR ARM WHEN PASSING OUT DUE TO HYPERGLYCEMIA. THEY WERE ABLE TO PUT A SPLINT ON THE PATIENT. THE PATIENT WAS RELEASED 2 HOURS LATER. THE POD WAS NOT WORN SINCE THERE WAS AN ERROR MESSAGE ON THE CONTROLLER AND WOULD NOT ALLOW HER TO GIVE A BOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036245 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-001827 10385083000022

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female