BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM

    MDR report key: 18104217 · Received November 9, 2023

    Report

    Report Number
    3016525500-2022-00016
    Event Type
    Injury
    Date Received
    November 9, 2023
    Date of Event
    August 24, 2022
    Report Date
    October 5, 2022
    Manufacturer
    BIGFOOT BIOMEDICAL,.INC
    Product Code
    QLG
    UDI-DI
    00850003506357
    PMA / PMN Number
    K202145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO ALLEGATION AGAINST THE SYSTEM WAS REPORTED BY THE CUSTOMER. BIGFOOT CONDUCTED A THOROUGH INVESTIGATION AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. BIGFOOT UNITY DOES NOT INCLUDE HIGH GLUCOSE ALERTS. REVIEW OF THE DATA LOGS SHOW THAT THE PATIENT WAS INTERACTING WITH THE SYSTEM AND ADMINISTERING INSULIN DOSES. THE INSULIN DOSE RECOMMENDATIONS WERE REVIEWED AND FOUND TO BE ISSUED PER SPECIFICATION. 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.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A CUSTOMER REPORTED A SEVERE HYPERGLYCEMIC EVENT, INCLUDING LOSS OF CONSCIOUSNESS, AND DKA. CUSTOMER WAS ADMITTED TO HOSPITAL WITH BLOOD GLUCOSE OVER 700 MG/DL, TREATED WITH INSULIN DRIP AND INJECTIONS. CUSTOMER WAS NOT WEARING A SENSOR AT THE TIME OF THE EVENT AND REPORTED HAVING THEIR INSULIN PRESCRIPTION ADJUSTED JUST PRIOR TO THE HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73855 BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM DIABETES MANAGEMENT SYSTEM QLG BIGFOOT BIOMEDICAL,.INC FG-300200 14374 00850003506357

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Unknown Hospitalization