BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM
Received Feb 22, 2022 · Event occurred Dec 29, 2021
Report 3016525500-2022-00001 · MDR key 13582051
Device
Generic name
Diabetes Management System
Manufacturer
Bigfoot Biomedical, Inc.Model number
FG-300206Catalog number
FG-300206
Lot number
00000333
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
56 YR · Male
- Hypoglycemia
- Confusion/ Disorientation
- Hypoglycemia
- Confusion/ Disorientation
Narrative
Description of Event or Problem
A PATIENT EXPERIENCED SYMPTOMS OF SEVERE HYPOGLYCEMIA FOR ABOUT AN HOUR, INCLUDING DISORIENTATION AND MEMORY LAPSE FOR SOME OF THE TIME. CUSTOMER WAS UNABLE TO SELF-TREAT, REQUIRING TREATMENT WITH GLUCOSE TABLETS AND ORANGE JUICE PROVIDED BY THEIR SON. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THE EVENT.
Additional Manufacturer Narrative
NO DEVICE ISSUES WERE REPORTED BY THE CUSTOMER. BIGFOOT CONDUCTED A THOROUGH INVESTIGATION AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. DATA LOGS FROM THE PATIENT'S UNITY SYSTEM WERE REVIEWED AND SHOWED THAT THE SYSTEM ISSUED LOW GLUCOSE ALERTS PER SPECIFICATION AND THE ALERTS WERE ALSO ACKNOWLEDGED. IF BIGFOOT LEARNS OF ANY NEW INFORMATION IN RELATION TO THIS CASE, ANOTHER INVESTIGATION WILL BE PERFORMED, AND A FOLLOW-UP REPORT WILL BE SUBMITTED. ALL PERTINENT INFORMATION AVAILABLE TO BIGFOOT HAS BEEN SUBMITTED.