Bigfoot Unity Diabetes Management System FG-300188Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00850003506258), received between May 27, 2022 and Nov 9, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 5 most recent of 5 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

  CUSTOMER REPORTED SEVERE HYPOGLYCEMIC EVENT ON (B)(6) 2023. CUSTOMER REPORTED A SEIZURE DURING THE EVENT, STATING THEY DID NOT LOSE CONSCIOUSNESS BUT WAS NOT IN COHERENT STATE. THEY DID NOT CHECK THEIR BLOOD GLUCOSE LEVEL ON A BLOOD GLUCOSE METER, BUT ASKED A CO-WORKER TO SCAN THE SENSOR BECAUSE CUSTOMER WAS NOT ABLE TO. THE SENSOR GLUCOSE VALUE WAS REPORTEDLY 69 MG/DL, BUT CUSTOMER FELT IT WAS LOWER PRIOR TO THE SCAN. CUSTOMER REQUESTED SOME ASSISTANCE FROM THE CO-WORKER WHO PROVIDED SODA TO TREAT THE LOW GLUCOSE CONDITIONS. THERE WAS NO DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THE EVENT.

  Patient problems: Cognitive Changes; Confusion/ Disorientation; Convulsion/Seizure; Hypoglycemia

  MAUDE report 18104222 ↗
• InjuryOct 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: Hyperglycemia

  MAUDE report 15588092 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: Hypoglycemia; Shaking/Tremors

  MAUDE report 15429785 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  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.

  Patient problems: Dizziness; Hypoglycemia; Shaking/Tremors

  MAUDE report 15071332 ↗
• InjuryMay 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Fatigue; Hyperglycemia

  MAUDE report 14528055 ↗

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