BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM

    MDR report key: 17484862 · Received August 8, 2023

    Report

    Report Number
    3016525500-2023-00032
    Event Type
    Injury
    Date Received
    August 8, 2023
    Report Date
    August 8, 2023
    Manufacturer
    BIGFOOT BIOMEDICAL, INC.
    Product Code
    QLG
    UDI-DI
    00850003506357
    PMA / PMN Number
    K202145N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BIGFOOT CONDUCTED A SYSTEM REVIEW FOR THE TWO-WEEK TIME PERIOD LEADING UP TO THE DATE OF REPORT. DURING THIS TIME, THE BIGFOOT UNITY SYSTEM ALERTED TO BOTH LOW AND VERY LOW GLUCOSE PER SPECIFICATION. NO DEVICE MALFUNCTION OCCURRED. IF BIGFOOT LEARNS OF ANY NEW INFORMATION PERTINENT TO THIS CASE, A FOLLOW-UP REPORT WILL BE SUBMITTED. ALL INFORMATION AVAILABLE TO BIGFOOT HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A POTENTIAL SEVERE HYPOGLYCEMIC EVENT WHILE USING BIGFOOT UNITY SYSTEM DURING PREVIOUS TWO WEEKS. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF MEDICAL INTERVENTION, DEATH, OR PERMANENT IMPAIRMENT ASSOCIATED WITH THE EVENT. CUSTOMER HAS NOT PROVIDED EXACT DATE OF EVENT. MULTIPLE OUTREACH ATTEMPTS WERE MADE TO COLLECT ADDITIONAL INFORMATION AND WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2100201 BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM DIABETES MANAGEMENT SYSTEM QLG BIGFOOT BIOMEDICAL, INC. FG-300200 23586 00850003506357

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Unknown Other