Bigfoot Unity Diabetes Management System FG-300185Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00850003506227), received between Mar 20, 2022 and Nov 9, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2023Device Displays Incorrect Message; Device Displays Incorrect Message

  ON (B)(6) 2022, THE CUSTOMER REPORTED THAT THE PERMANENT SENSOR LOSS ALERT WAS NOT ISSUED AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18104221 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT THEY EXPERIENCED HYPOGLYCEMIA AND WAS FOUND UNCONSCIOUS BY THEIR SPOUSE AT HOME. CUSTOMER STATED THAT THEY WERE NOT WEARING THEIR HEARING AIDS AT THE TIME OF EVENT AND WAS NOT ABLE TO HEAR THE LOW GLUCOSE ALERTS RAISED BY BIGFOOT UNITY. CUSTOMER FURTHER STATED THAT THE HYPOGLYCEMIC EVENT WAS DUE TO TRESIBA LASTING 40 HOURS IN THEIR SYSTEM NOT 24. CUSTOMER WAS RECENTLY SWITCHED OVER TO TRESIBA FROM LANTUS DUE TO LANTUS NOT LASTING 24 HOURS AND HAVING TO SPLIT THE LANTUS DOSE IN TWO SEPARATE DOSES. CUSTOMER WAS USING THE LANTUS CAP AND TRESIBA AT THE SAME TIME AND DOUBLE DOSED. THIS EVENT WAS COMMUNICATED TO THEIR DOCTOR.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 16574460 ↗
• InjuryMay 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Balance Problems; Cognitive Changes; Dizziness; Hypoglycemia

  MAUDE report 14504418 ↗
• InjuryMar 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER EXPERIENCED SYMPTOMS OF SEVERE HYPOGLYCEMIA INCLUDING BLURRED VISION AND LOSS OF CONSCIOUSNESS. THE CUSTOMER REQUIRED EMT ASSISTANCE AND EVALUATION OR TREATMENT BY AN HCP. TWO GLUCOSE TABLETS WERE ADMINISTERED, AND, IN THE AMBULANCE, THEY WERE GIVEN SOMETHING TO BRING THEIR GLUCOSE LEVEL UP (THROUGH IV). THE CUSTOMER WAS ADMITTED TO THE HOSPITAL, MONITORED, AND TREATED. THEY WERE HOSPITALIZED FOR 2 DAYS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THE EVENT.

  Patient problems: Blurred Vision; Hypoglycemia; Loss of consciousness

  MAUDE report 13831746 ↗

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