BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM

    MDR report key: 18103975 · Received November 9, 2023

    Report

    Report Number
    3016525500-2022-00015
    Event Type
    Injury
    Date Received
    November 9, 2023
    Date of Event
    September 23, 2022
    Report Date
    September 24, 2022
    Manufacturer
    BIGFOOT BIOMEDICAL,.INC
    Product Code
    QLG
    UDI-DI
    00850003506388
    PMA / PMN Number
    K202145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BIGFOOT REVIEWED THE CUSTOMER'S DATA LOGS FOR THE REPORTED TIMEFRAME OF THE EVENT, WHICH SHOWED THAT THE SYSTEM RESPONDED AS DESIGNED WHEN EXPERIENCING TEMPORARY DISRUPTIONS IN BLE COMMUNICATION BETWEEN THE SENSORY AND THE BIGFOOT UNITY MOBILE APP. ALL ALERTS WERE DELIVERED BY THE SYSTEM AS DESIGNED AND ALL DOSE RECOMMENDATIONS WERE DISPLAYED TO THE CUSTOMER AS CONFIGURED IN THEIR MOBILE APP SETTINGS. THERE IS NO INDICATION THAT THE SYSTEM DID NOT FUNCTION AS INTENDED. 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

    CUSTOMER REPORTED A SEVERE HYPERGLYCEMIA EVENT ON 09/23/2022. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THE EVENT. CUSTOMER STATED THAT THEY HAD A SEIZURE ON 09/23/2022. CUSTOMER STATED THAT THEY DID NOT SEEK MEDICAL ATTENTION FOR THIS EVENT. PRECEDING THE EVENT, THE CUSTOMER SCANNED THEIR SENSOR, WHICH DISPLAYED A READING OF GREATER THAN 400 MG/DL. CUSTOMER STATED THAT THEIR IPHONE WAS ALERTING FOR "SENSOR UNAVAILABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103508 BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM DIABETES MANAGEMENT SYSTEM QLG BIGFOOT BIOMEDICAL,.INC FG-300204 19879 00850003506388

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Unknown Other