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

Model Number	FG-300204
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperglycemia (1905); Convulsion/Seizure (4406)
Date of Event	09/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bigfoot reviewed the customer's data logs for the reported timeframe of the event, which showed that the system responded as designed when experiencing temporary disruptions in ble communication between the sensory and the bigfoot unity mobile app.All alerts were delivered by the system as designed and all dose recommendations were displayed to the customer as configured in their mobile app settings.There is no indication that the system did not function as intended.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.
Event or Problem Description
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".

• 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: 18103975
• Report Number: 3016525500-2022-00015
• Device Sequence Number: 14842003
• Product Code: QLG
• UDI-Device Identifier: 00850003506388
• UDI-Public: 0100850003506388
• 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): 09/24/2022

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: 01/31/2023
• Device Model Number: FG-300204
• Device Catalogue Number: FG-300204
• Device Lot Number: 19879
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2022
• Initial Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 61 YR
• Patient Sex: Unknown