Bigfoot Unity Diabetes Management System FG-300204Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850003506388), received between Sep 15, 2022 and Nov 9, 2023 — classified as 2 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 2 most recent of 2 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 A SEVERE HYPERGLYCEMIA EVENT ON 09/23/2022. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THE EVENT. CUSTOMER STATED THAT THEY HAD A SEIZURE ON 09/23/2022. CUSTOMER STATED THAT THEY DID NOT SEEK MEDICAL ATTENTION FOR THIS EVENT. PRECEDING THE EVENT, THE CUSTOMER SCANNED THEIR SENSOR, WHICH DISPLAYED A READING OF GREATER THAN 400 MG/DL. CUSTOMER STATED THAT THEIR IPHONE WAS ALERTING FOR "SENSOR UNAVAILABLE".

  Patient problems: Convulsion/Seizure; Hyperglycemia

  MAUDE report 18103975 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  Patient problems: Dizziness; Hypoglycemia; Shaking/Tremors

  MAUDE report 15429425 ↗

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