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

Model Number	FG-300206
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypoglycemia (1912); Dizziness (2194); Aphonia (4409)
Date of Event	03/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer experienced symptoms of severe hypoglycemia including lightheadedness and incoherence.The customer required assistance from their spouse who provided some carbohydrates (peanut butter crackers and milk) to treat the low glucose condition.There was no report of death or permanent impairment associated with the event.
Additional Manufacturer Narrative
Event description: a customer experienced symptoms of severe hypoglycemia including lightheadedness and incoherence.The customer required assistance from their spouse who provided some carbohydrates (peanut butter crackers and milk) to treat the low glucose condition.There was no report of death or permanent impairment associated with the event.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 patient's bigfoot unity app was not running at the time of the hypoglycemic event.The system therefore did not issue a low glucose alert during the period while the app was not running, per design.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 mccarthy boulevard; milpitas CA 95035
• Manufacturer (Section G): BIGFOOT BIOMEDICAL, INC.; 1820 mccarthy boulevard; milpitas CA 95035
• Manufacturer Contact: kate lee ; 1820 mccarthy boulevard; milpitas, CA 95035 ; 4087165600
• MDR Report Key: 14309699
• Report Number: 3016525500-2022-00003
• Device Sequence Number: 17387395
• Product Code: QLG
• UDI-Device Identifier: 00850003506401
• UDI-Public: 00850003506401
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2022

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: 05/31/2022
• Device Model Number: FG-300206
• Device Catalogue Number: FG-300206
• Device Lot Number: 10892
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• 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: 55 YR
• Patient Sex: Male