BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM

    MDR report key: 13582051 · Received February 22, 2022

    Report

    Report Number
    3016525500-2022-00001
    Event Type
    Injury
    Date Received
    February 22, 2022
    Date of Event
    December 29, 2021
    Report Date
    February 10, 2022
    Manufacturer
    BIGFOOT BIOMEDICAL, INC.
    Product Code
    QOG
    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

    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 SYSTEM ISSUED LOW GLUCOSE ALERTS PER SPECIFICATION AND THE ALERTS WERE ALSO ACKNOWLEDGED. 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 PATIENT EXPERIENCED SYMPTOMS OF SEVERE HYPOGLYCEMIA FOR ABOUT AN HOUR, INCLUDING DISORIENTATION AND MEMORY LAPSE FOR SOME OF THE TIME. CUSTOMER WAS UNABLE TO SELF-TREAT, REQUIRING TREATMENT WITH GLUCOSE TABLETS AND ORANGE JUICE PROVIDED BY THEIR SON. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672681 BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM DIABETES MANAGEMENT SYSTEM QOG BIGFOOT BIOMEDICAL, INC. FG-300206 00000333 00850003506401

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Other