BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM

    MDR report key: 18104220 · Received November 9, 2023

    Report

    Report Number
    3016525500-2022-00017
    Event Type
    Injury
    Date Received
    November 9, 2023
    Date of Event
    September 7, 2022
    Report Date
    October 6, 2022
    Manufacturer
    BIGFOOT BIOMEDICAL,.INC
    Product Code
    QLG
    UDI-DI
    00850003506401
    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. REVIEW OF THE DATA LOGS SHOW THAT THE SYSTEM ISSUED LOW GLUCOSE ALERTS PER SPECIFICATION AND SOME ALERTS WERE ACKNOWLEDGED BY THE CUSTOMER. AFTER ACKNOWLEDGEMENT OR RESOLUTION OF AN ALERT, THE SYSTEM RE-ISSUED LOW GLUCOSE ALERTS PER SPECIFICATION WHEN THE CUSTOMER'S GLUCOSE REACHED LOW AND VERY LOW LEVELS. 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 SYMPTOMS OF HYPOGLYCEMIA INCLUDING DIS-ORIENTATION AND TIREDNESS ON (B)(6) 2022. THE CUSTOMER DID NOT TREAT THEIR HYPOGLYCEMIC EVENT. THE CUSTOMER STATED THAT THEY RECEIVED LOW GLUCOSE ALERTS FROM THE BIGFOOT UNITY SYSTEM. THERE WAS NO REPORT OF THE CUSTOMER REQUIRING THIRD PARTY ASSISTANCE OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73858 BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM DIABETES MANAGEMENT SYSTEM QLG BIGFOOT BIOMEDICAL,.INC FG-300206 20310 00850003506401

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Unknown Other