BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM

    MDR report key: 15034596 · Received July 15, 2022

    Report

    Report Number
    3016525500-2022-00008
    Event Type
    Injury
    Date Received
    July 15, 2022
    Date of Event
    May 18, 2022
    Report Date
    July 15, 2022
    Manufacturer
    BIGFOOT BIOMEDICAL, INC.
    Product Code
    QLG
    UDI-DI
    00850003506357
    PMA / PMN Number
    K202145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER NARRATIVE: NO DEVICE ISSUES WERE REPORTED BY THE CUSTOMER. 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 THE SYSTEM ISSUED LOW GLUCOSE ALERTS PER SPECIFICATION AND SOME ALERTS WERE ACKNOWLEDGED BY THE CUSTOMER. AFTER ACKNOWLEDGEMENT OR RESOLUTION OF AN ALERT, THE SYSTEM RE-ISSUED LOW GLUCOSE ALERTS PER SPECIFICATION WHEN THE CUSTOMER'S GLUCOSE REACHED THE LOW AND VERY LOW LEVELS. DATA LOGS ALSO SHOWED THAT THE INSULIN RECOMMENDATIONS ISSUED BY THE SYSTEM MET SPECIFICATIONS. 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 DISORIENTATION AND DIZZINESS. THE CUSTOMER NEEDED MEDICAL INTERVENTION TO TREAT THEIR LOW GLUCOSE CONDITION AND WERE GIVEN GLUCOSE TABLETS, IV FLUIDS AND MONITORED IN THE HOSPITAL FOR SEVERAL DAYS. THE CUSTOMER STATED THAT THEY RECEIVED LOW GLUCOSE ALERTS FROM THE BIGFOOT UNITY SYSTEM. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897163 BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM DIABETES MANAGEMENT SYSTEM QLG BIGFOOT BIOMEDICAL, INC. FG-300200 13574 00850003506357

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Hospitalization