BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM

    MDR report key: 15071332 · Received July 21, 2022

    Report

    Report Number
    3016525500-2022-00009
    Event Type
    Injury
    Date Received
    July 21, 2022
    Date of Event
    June 20, 2022
    Report Date
    August 19, 2022
    Manufacturer
    BIGFOOT BIOMEDICAL, INC
    Product Code
    QLG
    UDI-DI
    00850003506258
    PMA / PMN Number
    K202145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION AVAILABLE TO BIGFOOT HAS BEEN SUBMITTED. A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER BIGFOOT LEARNS OF ANY NEW INFORMATION IN RELATION TO THIS CASE.

    Additional Manufacturer Narrative · 0

    NO DEVICE ISSUES WERE REPORTED BY THE CUSTOMER. UPON FOLLOW-UP REGARDING THE EVENT WITH THE CUSTOMER THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET THE SPECIFICATION. ALL PERTINENT 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. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF MEDICAL INTERVENTION, DEATH, OR PERMANENT IMPAIRMENT ASSOCIATED WITH THE EVENT. CUSTOMER HAS NOT PROVIDED A DATE OF EVENT TO ENABLE FURTHER DEVICE EVALUATION.

    Description of Event or Problem · 0

    CUSTOMER REPORTED A POTENTIAL SEVERE HYPOGLYCEMIC EVENT. THERE WAS NO REPORT OF MEDICAL INTERVENTION, DEATH, OR PERMANENT IMPAIRMENT ASSOCIATED WITH THE EVENT. CUSTOMER HAS NOT PROVIDED A DATE OF EVENT TO ENABLE FURTHER DEVICE EVALUATION, HOWEVER, POTENTIAL TIME OF EVENT COULD HAVE BEEN BETWEEN 6TH JUNE 2022 TO 20TH JUNE 2022. UPON FOLLOW-UP WITH THE CUSTOMER ON 07/05/2022 , THE FOLLOWING FACTS WERE REVEALED: CUSTOMERS HEALTHCARE PROVIDER HAD LOWERED THEIR INSULIN DOSE TO 30 UNITS AND CUSTOMER HAD BEEN EXPERIENCING LOW BLOOD SUGAR EVENTS OVERNIGHT. CUSTOMER DID NOT LOSE CONSCIOUSNESS DURING LOW BLOOD SUGAR EVENTS HOWEVER, CUSTOMER FELT SHAKY AND WOOZY. CUSTOMER WAS ABLE TO SELF TREAT THEIR LOW BLOOD SUGAR EVENTS WITH COKE AND GLUCOSE TABLETS. NO THIRD PARTY ASSISTANCE WAS REQUIRED. NO ALLEGATIONS WERE MADE AGAINST BIGFOOT UNITY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653198 BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM DIABETES MANAGEMENT SYSTEM QLG BIGFOOT BIOMEDICAL, INC FG-300188 14031 00850003506258

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Other