BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM

    MDR report key: 14309699 · Received May 6, 2022

    Report

    Report Number
    3016525500-2022-00003
    Event Type
    Injury
    Date Received
    May 6, 2022
    Date of Event
    March 27, 2022
    Report Date
    May 4, 2022
    Manufacturer
    BIGFOOT BIOMEDICAL, INC.
    Product Code
    QLG
    UDI-DI
    00850003506401
    PMA / PMN Number
    K202145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DESCRIPTION: A CUSTOMER EXPERIENCED SYMPTOMS OF SEVERE HYPOGLYCEMIA INCLUDING LIGHTHEADEDNESS AND INCOHERENCE. THE CUSTOMER REQUIRED ASSISTANCE FROM THEIR SPOUSE WHO PROVIDED SOME CARBOHYDRATES (PEANUT BUTTER CRACKERS AND MILK) TO TREAT THE LOW GLUCOSE CONDITION. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THE EVENT. MANUFACTURER NARRATIVE: NO DEVICE ISSUES WERE REPORTED BY THE CUSTOMER. BIGFOOT CONDUCTED A THOROUGH INVESTIGATION AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. DATA LOGS FROM THE PATIENT'S UNITY SYSTEM WERE REVIEWED AND SHOWED THAT THE PATIENT'S BIGFOOT UNITY APP WAS NOT RUNNING AT THE TIME OF THE HYPOGLYCEMIC EVENT. THE SYSTEM THEREFORE DID NOT ISSUE A LOW GLUCOSE ALERT DURING THE PERIOD WHILE THE APP WAS NOT RUNNING, PER DESIGN. 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

    A CUSTOMER EXPERIENCED SYMPTOMS OF SEVERE HYPOGLYCEMIA INCLUDING LIGHTHEADEDNESS AND INCOHERENCE. THE CUSTOMER REQUIRED ASSISTANCE FROM THEIR SPOUSE WHO PROVIDED SOME CARBOHYDRATES (PEANUT BUTTER CRACKERS AND MILK) TO TREAT THE LOW GLUCOSE CONDITION. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438161 BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM DIABETES MANAGEMENT SYSTEM QLG BIGFOOT BIOMEDICAL, INC. FG-300206 10892 00850003506401

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Other