MAUDE Adverse Event Report: BIGFOOT BIOMEDICAL,.INC BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM

Model Number	FG-300185
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418)
Date of Event	02/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported that they experienced hypoglycemia and was found unconscious by their spouse at home.Customer stated that they were not wearing their hearing aids at the time of event and was not able to hear the low glucose alerts raised by bigfoot unity.Customer further stated that the hypoglycemic event was due to tresiba lasting 40 hours in their system not 24.Customer was recently switched over to tresiba from lantus due to lantus not lasting 24 hours and having to split the lantus dose in two separate doses.Customer was using the lantus cap and tresiba at the same time and double dosed.This event was communicated to their doctor.
Additional Manufacturer Narrative
Bigfoot conducted a thorough investigation, and there was no indication that the product failed to meet the specification.Data logs from the patient's unity system were reviewed and showed that the system issued 5 low glucose alerts per specification and 4 alerts were acknowledged and resolved by the customer.Doses were recommended per specification.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.

• Brand Name: BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM
• Common Device Name: DIABETES MANAGEMENT SYSTEM
• Manufacturer (Section D): BIGFOOT BIOMEDICAL,.INC; 1820 mc carthy boulevard; milpitas CA 95035
• Manufacturer (Section G): BIGFOOT BIOMEDICAL,.INC; 1820 mc carthy boulevard; milpitas CA 95035
• Manufacturer Contact: kate lee ; 1820 mc carthy boulevard; milpitas, CA 95035 ; 4087165600
• MDR Report Key: 16574460
• Report Number: 3016525500-2023-00025
• Device Sequence Number: 7170238
• Product Code: QLG
• UDI-Device Identifier: 00850003506227
• UDI-Public: 00850003506227
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K202145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2023
• Device Model Number: FG-300185
• Device Catalogue Number: FG-300185
• Device Lot Number: 24655
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Prefer Not To Disclose