BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM

    MDR report key: 14464292 · Received May 20, 2022

    Report

    Report Number
    3016525500-2022-00004
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    April 21, 2022
    Report Date
    May 19, 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

    MANUFACTURER NARRATIVE: NO COMPLAINTS OR ADVERSE EVENTS WERE REPORTED FROM THE FIELD. BIGFOOT IS REPORTING THIS ISSUE PROACTIVELY SINCE THERE IS A REMOTE POSSIBILITY OF MISSING CRITICAL ALERTS. THIS IS AN ISSUE INTRODUCED BY APPLE IOS 15 AND LATER.

    Description of Event or Problem · 0

    A BIGFOOT EMPLOYEE DISCOVERED THE FOLLOWING SCENARIO: THERE EXISTS A MULTIPLE-FAULT USE CASE FOR ALL IOS 15 VERSIONS THAT IF THE APP IS IN THE FOREGROUND FOR A PERIOD OF GREATER THAN FIVE MINUTES OR MORE (E.G. DISABLED LOCK SCREEN), THE MODAL FOR NOTIFICATIONS WILL SHOW VISUALLY TO THE USER BUT DUE TO THE ISSUE WITH APPLE IOS 15, THE SOUND AND VIBRATION WILL NOT ANNUNCIATE. THIS CASE IS AN ISSUE WITH APPLE IOS 15 VERSIONS AND NOT SPECIFIC TO THE BIGFOOT UNITY APP, WHERE THE OPERATING SYSTEM DOES NOT SEND VIBRATION/SOUND IN THE CASE THAT A SOUND/VIBE-ONLY NOTIFICATION IS TRIGGERED WHEN THE APP IS IN THE FOREGROUND. THIS WOULD MANIFEST IF THE USER WERE TO DISABLE THE LOCK OR SLEEP FEATURE ON THEIR PHONE. THERE IS A REMOTE POSSIBILITY THAT THIS MALFUNCTION, IF IT WERE TO RECUR, COULD RESULT IN MISSING A LOW GLUCOSE ALERT IF A PATIENT IS NOT LOOKING AT THEIR PHONE. NO COMPLAINTS FROM THE FIELD HAVE BEEN RECEIVED AS OF (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1658770 BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM DIABETES MANAGEMENT SYSTEM QLG BIGFOOT BIOMEDICAL, INC. SW-300842, V1.4.5

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown