Bigfoot Unity Diabetes Management System FG-300200Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850003506357), received between Jul 15, 2022 and Nov 9, 2023 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, A CUSTOMER REPORTED A SEVERE HYPERGLYCEMIC EVENT, INCLUDING LOSS OF CONSCIOUSNESS, AND DKA. CUSTOMER WAS ADMITTED TO HOSPITAL WITH BLOOD GLUCOSE OVER 700 MG/DL, TREATED WITH INSULIN DRIP AND INJECTIONS. CUSTOMER WAS NOT WEARING A SENSOR AT THE TIME OF THE EVENT AND REPORTED HAVING THEIR INSULIN PRESCRIPTION ADJUSTED JUST PRIOR TO THE HOSPITALIZATION.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Loss of consciousness

  MAUDE report 18104217 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Hypoglycemia

  MAUDE report 17484862 ↗
• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER EXPERIENCED SYMPTOMS OF SEVERE HYPOGLYCEMIA INCLUDING DISORIENTATION AND DIZZINESS. THE CUSTOMER NEEDED MEDICAL INTERVENTION TO TREAT THEIR LOW GLUCOSE CONDITION AND WERE GIVEN GLUCOSE TABLETS, IV FLUIDS AND MONITORED IN THE HOSPITAL FOR SEVERAL DAYS. THE CUSTOMER STATED THAT THEY RECEIVED LOW GLUCOSE ALERTS FROM THE BIGFOOT UNITY SYSTEM. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THE EVENT.

  Patient problems: Cognitive Changes; Confusion/ Disorientation; Dizziness; Hypoglycemia

  MAUDE report 15034596 ↗

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