BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM

    MDR report key: 14528055 · Received May 27, 2022

    Report

    Report Number
    3016525500-2022-00006
    Event Type
    Injury
    Date Received
    May 27, 2022
    Date of Event
    February 22, 2022
    Report Date
    May 26, 2022
    Manufacturer
    BIGFOOT BIOMEDICAL, INC.
    Product Code
    QLG
    UDI-DI
    00850003506258
    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. THE CUSTOMER DID NOT KNOW THE DATE THE EVENT TOOK PLACE. BIGFOOT CONDUCTED A THOROUGH INVESTIGATION AND FOUND THAT THE EVENT POTENTIALLY OCCURRED IN FEBRUARY DUE TO THE SEVERAL INSTANCES OF PROLONGED HIGH GLUCOSE IDENTIFIED. INVESTIGATION FOUND THAT THE SYSTEM PERFORMED AS INTENDED DURING THIS TIME. INSTANCES OF LOW GLUCOSE WERE ALSO DISCOVERED AND THE SYSTEM PERFORMED AS INTENDED AND RAISED LOW GLUCOSE ALERTS PER SPECIFICATION IN EACH INSTANCE. THEREFORE, THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET 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. JUSTIFICATION FOR DELAY IN SUBMISSION: BIGFOOT BECAME AWARE OF THE HYPERGLYCEMIC EVENT ON (B)(6) 2022 BUT UPON INITIAL INVESTIGATION, NO DEVICE DATA WAS FOUND FOR THE MONTH OF MARCH, INDICATING THAT THE CUSTOMER WASN'T USING THE SYSTEM AT THE TIME. SUCCESSFUL CONTACT WITH THE CUSTOMER ON (B)(6) 2022 INDICATED THAT THE EVENT POTENTIALLY HAPPENED IN THE MONTH OF APRIL, HOWEVER, THERE WAS ALSO NO DEVICE DATA FOUND FOR THE MONTH OF APRIL. FOR COMPLETENESS, BIGFOOT EXTENDED THE INVESTIGATION TO REVIEW THE LAST AVAILABLE GLUCOSE DATA IN THE MONTH OF FEBRUARY. BIGFOOT WAS THEN ABLE TO IDENTIFY A PERIOD OF POTENTIAL HYPERGLYCEMIA TAKING PLACE IN FEBURARY THAT WAS CONSISTENT WITH THE EVENT DESCRIBED BY THE CUSTOMER.

    Description of Event or Problem · 0

    A CUSTOMER EXPERIENCED SYMPTOMS OF SEVERE HYPERGLYCEMIA INCLUDING FEELING WEAK WHEN THEY WOKE UP AT APPROXIMATELY 1:00 AM EST. THE CUSTOMER DID NOT KNOW THE DATE THE EVENT TOOK PLACE. THEY DID NOT CHECK THEIR BLOOD GLUCOSE LEVEL ON A BLOOD GLUCOSE METER BUT THE SENSOR GLUCOSE VALUES WERE ABOVE 400MG/DL. THEY WERE TREATED IN THE EMERGENCY ROOM WITH INSULIN AND IV FLUIDS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1993347 BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM DIABETES MANAGEMENT SYSTEM QLG BIGFOOT BIOMEDICAL, INC. FG-300188 00000364 00850003506258

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Other