BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM

    MDR report key: 18104222 · Received November 9, 2023

    Report

    Report Number
    3016525500-2023-00024
    Event Type
    Injury
    Date Received
    November 9, 2023
    Date of Event
    January 23, 2023
    Report Date
    February 23, 2023
    Manufacturer
    BIGFOOT BIOMEDICAL,.INC
    Product Code
    QLG
    UDI-DI
    00850003506258
    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 DID NOT MEET THE SPECIFICATION. DATA LOGS FROM THE PATIENT'S UNITY SYSTEM WERE REVIEWED AND SHOWED THAT THE SYSTEM ISSUED A LOW GLUCOSE ALERT PER SPECIFICATION AND THE ALERT WAS ACKNOWLEDGED AND RESOLVED. THEREFORE, THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET 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 SEVERE HYPOGLYCEMIC EVENT ON (B)(6) 2023. CUSTOMER REPORTED A SEIZURE DURING THE EVENT, STATING THEY DID NOT LOSE CONSCIOUSNESS BUT WAS NOT IN COHERENT STATE. THEY DID NOT CHECK THEIR BLOOD GLUCOSE LEVEL ON A BLOOD GLUCOSE METER, BUT ASKED A CO-WORKER TO SCAN THE SENSOR BECAUSE CUSTOMER WAS NOT ABLE TO. THE SENSOR GLUCOSE VALUE WAS REPORTEDLY 69 MG/DL, BUT CUSTOMER FELT IT WAS LOWER PRIOR TO THE SCAN. CUSTOMER REQUESTED SOME ASSISTANCE FROM THE CO-WORKER WHO PROVIDED SODA TO TREAT THE LOW GLUCOSE CONDITIONS. THERE WAS NO DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73860 BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM DIABETES MANAGEMENT SYSTEM QLG BIGFOOT BIOMEDICAL,.INC FG-300188 25071 00850003506258

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Unknown Other