BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 CONTROLLER

    MDR report key: 19467419 · Received June 5, 2024

    Report

    Report Number
    3004464228-2024-20628
    Event Type
    Injury
    Date Received
    June 5, 2024
    Date of Event
    May 27, 2024
    Report Date
    June 14, 2024
    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

    THE RETURNED DEVICE WAS EVALUATED AND THE CASE DESCRIPTION STATES THAT THE USER RECEIVED A POD ERROR WITH REFERENCE CODE 19-12800-00251-034. THE PHYSICAL CONTROLLER WAS NOT RECEIVED FOR INVESTIGATION. ANDROID LOG FILES FROM THE COMPLAINT DEVICE WERE UPLOADED TO THE CLOUD SYSTEM BY THE USER AND DOWNLOADED FOR INVESTIGATION. INSPECTION OF THE ANDROID LOG FILES CONFIRMED THE REPORTED POD ERROR AND THE GENERATION OF FOUR OTHER POD ERRORS WITH ERROR CODES ENDING IN -034. INSPECTION OF THE LOG FILES FROM THE CONTROLLER FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THE GENERATED POD ALARMS. THE EXACT CAUSE OF THE REPORTED POD ALARMS COULD NOT BE DETERMINED FROM THE CONTROLLER LOGS.

    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 HOSPITALIZATION AND DIABETIC KETOACIDOSIS. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 580 MG/DL. THE PATIENT REPORTS DUE TO THEIR CONTROLLER NOT COMMUNICATING WITH PODS THEY WERE UNABLE TO ACTIVATE A POD AS THEY HAD RUN OUT OF INSULIN. ONCE AT THE HOSPITAL THE PATIENT WAS TREATED WITH INTRAVENOUS FLUIDS AS WELL AS AN INSULIN DRIP. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER 24 HOURS. THE PATIENT REPORTS THEY ARE USING A DASH CONTROLLER AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807336 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000409 10385083000022

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female Hospitalization