BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM

    MDR report key: 14812542 · Received June 25, 2022

    Report

    Report Number
    3016525500-2022-00007
    Event Type
    Malfunction
    Date Received
    June 25, 2022
    Date of Event
    March 20, 2022
    Report Date
    June 24, 2022
    Manufacturer
    BIGFOOT BIOMEDICAL, INC.
    Product Code
    QLG
    PMA / PMN Number
    K202145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO COMPLAINTS OR ADVERSE EVENTS WERE REPORTED FROM THE FIELD. BIGFOOT IS REPORTING THIS ISSUE PROACTIVELY SINCE CRITICAL ALERTS WERE NOT ISSUED TO THIS PATIENT.

    Description of Event or Problem · 0

    A BIGFOOT EMPLOYEE BECAME AWARE OF THE FOLLOWING WHILE REVIEWING DATA LOGS: WHEN A CUSTOMER RE-PAIRED THEIR RAPID ACTING INSULIN PEN CAP TO THE BIGFOOT UNITY MOBILE APP, THE SENSOR THAT WAS ALREADY PAIRED TO THE MOBILE APP DISCONNECTED FROM THE SYSTEM AND DID NOT ISSUE CRITICAL ALERTS. THERE IS EVIDENCE THAT THE MOBILE APP DISPLAYED A "GLUCOSE ALERTS UNAVAILABLE. START NEW SENSOR" MESSAGE TO THE PATIENT, BUT SINCE NO VIBRATORY OR AUDIBLE "SENSOR UNAVAILABLE" ALERTS WERE ISSUED AFTER THE DISCONNECTION, THE PRODUCT DID NOT FUNCTION AS INTENDED. HOWEVER, VALID GLUCOSE VALUES WERE AVAILABLE TO THE PATIENT EVERY TIME THEY SCANNED THE SENSOR WITH THEIR PEN CAP. EVALUATION OF THEIR GLUCOSE DATA SHOWED THAT THE PATIENT DID NOT ENTER THE 'LOW GLUCOSE' RANGE WHILE THE SENSOR WAS DISCONNECTED FROM THE BIGFOOT UNITY MOBILE APP AND THERE IS NO INDICATION THAT AN ADVERSE EVENT OCCURRED IN THIS INSTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959048 BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM DIABETES MANAGEMENT SYSTEM QLG BIGFOOT BIOMEDICAL, INC. SW-300842, V1.5.2

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male