BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM

    MDR report key: 17436431 · Received August 1, 2023

    Report

    Report Number
    3016525500-2023-00029
    Event Type
    Injury
    Date Received
    August 1, 2023
    Date of Event
    April 29, 2023
    Report Date
    August 1, 2023
    Manufacturer
    BIGFOOT BIOMEDICAL, INC.
    Product Code
    QLG
    UDI-DI
    00850003506234
    PMA / PMN Number
    K202145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BIGFOOT CONDUCTED A SYSTEM REVIEW FOR THE TIME PERIOD LEADING UP TO THE ADVERSE EVENT. DURING THIS TIME, THE BIGFOOT UNITY SYSTEM WAS FUNCTIONING PER SPECIFICATION. REVIEW OF THE DATA LOGS SHOW THAT THE PATIENT WAS INTERACTING WITH THE SYSTEM AND RECEIVING CORRECTION DOSE RECOMMENDATIONS AND SYSTEM ALERTS. IF BIGFOOT LEARNS OF ANY NEW INFORMATION IN RELATION TO THIS CASE, ANOTHER INVESTIGATION WILL BE PERFORMED, AND A FOLLOW-UP REPORT WILL BE SUBMITTED. ALL PERTINENT INFORMATION AVAILABLE TO BIGFOOT HAS BEEN SUBMITTED. PLEASE NOTE THAT THIS MDR IS BEING SUBMITTED TO CORRECT AN ERROR IN THE FEI FOR MDR 301552550002023-0026 WHICH WAS RECEIVED BY FDA ON 05-26-2023.

    Description of Event or Problem · 0

    PATIENT REPORTED THAT THEY WERE HOSPITALIZED WITH BG LEVELS OF 1500 MG/DL. PATIENT REPORTED THAT THEIR LONG-ACTING INSULIN WAS CHANGED RECENTLY FROM NOVOLIN-N (USING VIAL/SYRINGE) TO TOUJEO (USING INSULIN PEN), AND THEY JUST STARTED USING BIGFOOT UNITY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634877 BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM DIABETES MANAGEMENT SYSTEM QLG BIGFOOT BIOMEDICAL, INC. FG-300186 32124 00850003506234

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Life Threatening| R| H