BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM

    MDR report key: 14504418 · Received May 26, 2022

    Report

    Report Number
    3016525500-2022-00005
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    April 23, 2022
    Report Date
    May 24, 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

    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 A LOW GLUCOSE ALERT PER SPECIFICATION AND THE ALERT WAS ACKNOWLEDGED. AFTER INITIAL ACKNOWLEDGEMENT, THE SYSTEM ISSUED ALERTS AGAIN WHEN THE CUSTOMER'S GLUCOSE REACHED THE LOW AND VERY LOW LEVELS AND THESE ALERTS RESOLVED PER 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

    A CUSTOMER EXPERIENCED SYMPTOMS OF SEVERE HYPOGLYCEMIA INCLUDING LIGHTHEADEDNESS, STUMBLING/FALLING, FEELING LETHARGIC, AND HAVING A HARD TIME REMEMBERING. THE CUSTOMER REQUIRED ASSISTANCE FROM THEIR STEP-SON WHO PROVIDED SOME CARBOHYDRATES (HAMBURGER STEAK, SALAD, AND SLAW) TO TREAT THE LOW GLUCOSE CONDITION. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342857 BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM DIABETES MANAGEMENT SYSTEM QLG BIGFOOT BIOMEDICAL, INC. FG-300185 2590 00850003506227

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Other