BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM
Report
- Report Number
- 3016525500-2025-00050
- Event Type
- Malfunction
- Date Received
- July 25, 2025
- Date of Event
- January 28, 2025
- Report Date
- August 25, 2025
- Manufacturer
- BIGFOOT BIOMEDICAL, INC
- Product Code
- QLG
- UDI-DI
- 00850003506173
- PMA / PMN Number
- K202145
- Removal / Correction Number
- 3016525500/05162025/C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- 003
Narratives
THIS SERVES AS A CORRECTION REPORT. SECTION D4 (PRIMARY UDI NUMBER) WAS INCORRECTLY DOCUMENTED IN THE PREVIOUS REPORT. CORRECTION HAS BEEN MADE.
FOLLOWING THE SUBMISSION OF A CORRECTION/REMOVAL FOR CERTAIN BIGFOOT UNITY DEVICES, IT HAS BEEN DETERMINED THAT THIS COMPLAINT IS A REPORTABLE MALFUNCTION.
A CUSTOMER REPORTED RECEIVING DEVICE ERROR FROM A BIGFOOT UNITY DEVICE. THIS IS A KNOWN ISSUE FOR THE SERIAL NUMBER ASSOCIATED WITH THIS COMPLAINT, ADDRESSED BY THE FIELD ACTION FA-001 (FDA RECALL 3016525500/05162025/C). THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
A CUSTOMER REPORTED RECEIVING DEVICE ERROR FROM A BIGFOOT UNITY DEVICE. THIS IS A KNOWN ISSUE FOR THE SERIAL NUMBER ASSOCIATED WITH THIS COMPLAINT, ADDRESSED BY THE FIELD ACTION FA-001 (FDA RECALL 3016525500/05162025/C). THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2287891 | BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM | DIABETES MANAGEMENT SYSTEM | QLG | BIGFOOT BIOMEDICAL, INC | ASM-10046 | 45869 | 00850003506173 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Unknown |