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

Model Number	FG-300205
Health Effect - Clinical Codes	Hypoglycemia (1912); Tachycardia (2095); Loss of consciousness (2418)
Date of Event	07/25/2022
Type of Reportable Event	Serious Injury

• 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 mc carthy boulevard; milpitas CA 95035
• Manufacturer Contact: kate lee ; 1820 mc carthy boulevard; milpitas, CA 95035 ; 4087165600
• MDR Report Key: 15272757
• Report Number: 3016525500-2022-00013
• Device Sequence Number: 5493205
• Product Code: QLG
• UDI-Device Identifier: 00850003506395
• UDI-Public: 00850003506395
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K202145N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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 Model Number: FG-300205
• Device Catalogue Number: FG-300205
• Device Lot Number: 13516
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 09/12/2023
• Date Device Manufactured: 12/13/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female