BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM

    MDR report key: 13831746 · Received March 20, 2022

    Report

    Report Number
    3016525500-2022-00002
    Event Type
    Injury
    Date Received
    March 20, 2022
    Date of Event
    February 9, 2022
    Report Date
    March 17, 2022
    Manufacturer
    BIGFOOT BIOMEDICAL, INC.
    Product Code
    QLG
    UDI-DI
    00850003506227
    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

    CUSTOMER REPORTED THAT THEY DID NOT RECEIVE AN ALERT FROM THE BIGFOOT UNITY SYSTEM. THEY SUSPECT IT WAS BECAUSE THEY WERE TOO FAR FROM THEIR PHONE. 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 THERE WAS NO BLE COMMUNICATION BETWEEN THE SENSOR AND THE BIGFOOT UNITY MOBILE APP AT THE TIME OF THE HYPOGLYCEMIC EVENT. THE SYSTEM ISSUED A SENSOR UNAVAILABLE ALERT PER SPECIFICATION AND THE ALERT WAS ALSO ACKNOWLEDGED ON THE PATIENT'S PHONE. THE SYSTEM DID NOT ISSUE A LOW GLUCOSE ALERT DURING THE PERIOD OF NON-CONNECTIVITY, PER SPECIFICATION. THE SENSOR IS NOT MANUFACTURED BY BIGFOOT AND THE MANUFACTURER OF THE SENSOR HAS BEEN NOTIFIED OF THIS ADVERSE EVENT. 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 CUSTOMER EXPERIENCED SYMPTOMS OF SEVERE HYPOGLYCEMIA INCLUDING BLURRED VISION AND LOSS OF CONSCIOUSNESS. THE CUSTOMER REQUIRED EMT ASSISTANCE AND EVALUATION OR TREATMENT BY AN HCP. TWO GLUCOSE TABLETS WERE ADMINISTERED, AND, IN THE AMBULANCE, THEY WERE GIVEN SOMETHING TO BRING THEIR GLUCOSE LEVEL UP (THROUGH IV). THE CUSTOMER WAS ADMITTED TO THE HOSPITAL, MONITORED, AND TREATED. THEY WERE HOSPITALIZED FOR 2 DAYS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510922 BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM DIABETES MANAGEMENT SYSTEM QLG BIGFOOT BIOMEDICAL, INC. FG-300185 00000197 00850003506227

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization| R