Bigfoot Unity Diabetes Management System FG-300202Recalls & reported problems

Bigfoot Biomedical, Inc. · Bigfoot Unity Diabetes Management System for Novolog-Aspart and Basaglar Only · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850003506364), received between Nov 9, 2023 and Nov 9, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (1 report).

1 other recall cover devices cleared under the same FDA submission (K202145); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Application Program Freezes or Fails to Launch1
Display or Visual Feedback Problem1
No Audible Prompt/Feedback1
No Visual Prompts/Feedback1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 9, 2023Display or Visual Feedback Problem; No Audible Prompt/Feedback; No Visual Prompts/Feedback; Application Program Freezes or Fails to Launch; Display or Visual Feedback Problem; No Audible Prompt/Feedback; No Visual Prompts/Feedback; Application Program Freezes or Fails to Launch
CUSTOMER REPORTED THAT WHEN THEY TRIED TO OPEN THE BIGFOOT UNITY APP AND IT DISPLAYS BLANK SCREEN WITH A BIGFOOT LOGO AND THEN CLOSES OUT ON ITS OWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18104225 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K202145. One submission often covers many models, so check the product and lot details in each record.

Z-1997-2025 · May 21, 2025 · Open, Classified
Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmwar

Device details

UDI-DI	`00850003506364`
Brand	Bigfoot Unity Diabetes Management System
Model	FG-300202
Company	Bigfoot Biomedical, Inc.
Product code	QLG · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Class	Class 2
FDA submission	K202145
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 14, 2025

Device type (GMDN): Percutaneous interstitial fluid glucose monitoring system, electrochemical

An assembly of electrically-powered, portable devices intended to continuously monitor interstitial fluid glucose concentrations in a patient with diabetes mellitus, using an invasive electrochemical technique. It consists of an electrochemical, percutaneously-inserted electrode that physically connects to a cable or transmitter which communicates with a monitor or receiver (not included) that captures, stores, and converts the sensor signals to glucose concentrations for display. The system may be used in the home and clinical settings, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.

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All Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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