BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM

    MDR report key: 17438515 · Received August 1, 2023

    Report

    Report Number
    3016525500-2023-00031
    Event Type
    Injury
    Date Received
    August 1, 2023
    Date of Event
    May 5, 2023
    Report Date
    August 1, 2023
    Manufacturer
    BIGFOOT BIOMEDICAL, INC.
    Product Code
    QLG
    UDI-DI
    00850003506241
    PMA / PMN Number
    K202145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BIGFOOT CONDUCTED A SYSTEM REVIEW FOR THE TWO-WEEK TIME PERIOD LEADING UP TO THE DATE OF REPORT. DURING THIS TIME, THE BIGFOOT UNITY SYSTEM ALERTED TO BOTH LOW AND VERY LOW GLUCOSE PER SPECIFICATION. NO DEVICE MALFUNCTION OCCURRED. IF BIGFOOT LEARNS OF ANY NEW INFORMATION PERTINENT TO THIS CASE, A FOLLOW-UP REPORT WILL BE SUBMITTED. ALL INFORMATION AVAILABLE TO BIGFOOT HAS BEEN SUBMITTED. PLEASE NOTE THAT THIS MDR IS BEING SUBMITTED TO CORRECT AN ERROR IN THE FEI FOR MDR 30155255000-2023-0028 WHICH WAS RECEIVED BY FDA ON 06-01-2023.

    Description of Event or Problem · 0

    PATIENT REPORTED THAT THEY HAD EXPERIENCED A SEVERE HYPOGLYCEMIC EVENT DURING THE PREVIOUS TWO WEEKS. NO FURTHER INFORMATION WAS PROVIDED. MULTIPLE ATTEMPTS TO COLLECT ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634991 BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM DIABETES MANAGEMENT SYSTEM QLG BIGFOOT BIOMEDICAL, INC. FG-300187 31984 00850003506241

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Other