BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM

    MDR report key: 16574460 · Received March 20, 2023

    Report

    Report Number
    3016525500-2023-00025
    Event Type
    Injury
    Date Received
    March 20, 2023
    Date of Event
    February 23, 2023
    Report Date
    March 20, 2023
    Manufacturer
    BIGFOOT BIOMEDICAL,.INC
    Product Code
    QLG
    UDI-DI
    00850003506227
    PMA / PMN Number
    K202145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BIGFOOT CONDUCTED A THOROUGH INVESTIGATION, AND THERE WAS NO INDICATION THAT THE PRODUCT FAILED TO MEET THE SPECIFICATION. DATA LOGS FROM THE PATIENT'S UNITY SYSTEM WERE REVIEWED AND SHOWED THAT THE SYSTEM ISSUED 5 LOW GLUCOSE ALERTS PER SPECIFICATION AND 4 ALERTS WERE ACKNOWLEDGED AND RESOLVED BY THE CUSTOMER. DOSES WERE RECOMMENDED 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

    CUSTOMER REPORTED THAT THEY EXPERIENCED HYPOGLYCEMIA AND WAS FOUND UNCONSCIOUS BY THEIR SPOUSE AT HOME. CUSTOMER STATED THAT THEY WERE NOT WEARING THEIR HEARING AIDS AT THE TIME OF EVENT AND WAS NOT ABLE TO HEAR THE LOW GLUCOSE ALERTS RAISED BY BIGFOOT UNITY. CUSTOMER FURTHER STATED THAT THE HYPOGLYCEMIC EVENT WAS DUE TO TRESIBA LASTING 40 HOURS IN THEIR SYSTEM NOT 24. CUSTOMER WAS RECENTLY SWITCHED OVER TO TRESIBA FROM LANTUS DUE TO LANTUS NOT LASTING 24 HOURS AND HAVING TO SPLIT THE LANTUS DOSE IN TWO SEPARATE DOSES. CUSTOMER WAS USING THE LANTUS CAP AND TRESIBA AT THE SAME TIME AND DOUBLE DOSED. THIS EVENT WAS COMMUNICATED TO THEIR DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1649686 BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM DIABETES MANAGEMENT SYSTEM QLG BIGFOOT BIOMEDICAL,.INC FG-300185 24655 00850003506227

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Prefer Not To Disclose Other