BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM

    MDR report key: 15620775 · Received October 17, 2022

    Report

    Report Number
    3016525500-2022-00014
    Event Type
    Injury
    Date Received
    October 17, 2022
    Date of Event
    July 5, 2022
    Report Date
    September 20, 2022
    Manufacturer
    BIGFOOT BIOMEDICAL,.INC
    Product Code
    QLG
    UDI-DI
    0085003506227
    PMA / PMN Number
    K202145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THE DATE OF EVENT AS (B)(6) 2022. BIGFOOT CONDUCTED A THOROUGH INVESTIGATION AND DID NOT FIND ANY LOW GLUCOSE EVENTS ON (B)(6) 2022. THE INVESTIGATION WAS THEREFORE EXPANDED TO THE LAST VISIBLE EVENTS CONSISTENT WITH THE PATIENT'S REPORT OF LOW GLUCOSE. BASED ON THE DATA AVAILABLE, IT IS LIKELY THAT THE EVENT OCCURRED ON (B)(6) 2022. DATA LOGS FROM THE PATIENT'S UNITY SYSTEM WERE REVIEWED AND SHOWED THAT THE SYSTEM ISSUED LOW GLUCOSE ALERTS PER SPECIFICATION AND ALERTS WERE ACKNOWLEDGED BY THE CUSTOMER OR RESOLVED PER SPECIFICATION. AFTER ACKNOWLEDGEMENT OR RESOLUTION OF AN ALERT, THE SYSTEM RE-ISSUED LOW GLUCOSE ALERTS PER SPECIFICATION WHEN THE CUSTOMER'S GLUCOSE REACHED LOW OR VERY LOW LEVELS. INVESTIGATION SHOWED THAT 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 A POTENTIAL ADVERSE EVENT TO BIGFOOT ON 08/18/2022. UPON FOLLOW-UP ON 08/25/2022, THE FOLLOWING INFORMATION WAS OBTAINED: CUSTOMER INDICATED THAT THE SENSOR ISSUED A LOW GLUCOSE ALERT DURING LATE MORNING HOURS. CUSTOMER'S CAREGIVER TREATED THE LOW GLUCOSE WITH OATMEAL. POST TREATMENT, GLUCOSE LEVELS RAISED TO 109 MG/DL. CUSTOMER LATER ADMINISTERED A RECOMMENDED DOSE OF INSULIN SUGGESTED BY BIGFOOT UNITY. AT APPROXIMATELY AROUND 1:30PM, CUSTOMER'S CAREGIVER FOUND THEM UNCONSCIOUS IN BED. CUSTOMER RECALLS A LOW GLUCOSE READING AS 42MG/DL. AMBULANCE/EMT WAS CONTACTED AND THEY WERE TRANSPORTED TO A HOSPITAL. EMT PROVIDED THE CUSTOMER WITH "INJECTIONS" AND IV FLUIDS TO TREAT THE LOW GLUCOSE CONDITION. CUSTOMER WAS IN THE HOSPITAL FOR A FEW DAYS BEFORE THEY WERE RELEASED TO A REHAB FACILITY. CUSTOMER ALLEGED THAT THE RECOMMENDED INSULIN DOSE MAY HAVE CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341155 BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM DIABETES MANAGEMENT SYSTEM QLG BIGFOOT BIOMEDICAL,.INC FG-300185 00000197 0085003506227

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Unknown Hospitalization| O