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

Model Number	FG-300200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypoglycemia (1912)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bigfoot conducted a system review for the two-week time period leading up to the date of report.During this time, the bigfoot unity system alerted to both low and very low glucose per specification.No device malfunction occurred.If bigfoot learns of any new information pertinent to this case, a follow-up report will be submitted.All information available to bigfoot has been submitted.
Event or Problem Description
Customer reported a potential severe hypoglycemic event while using bigfoot unity system during previous two weeks.No further information was provided.There was no report of medical intervention, death, or permanent impairment associated with the event.Customer has not provided exact date of event.Multiple outreach attempts were made to collect additional information and were unsuccessful.

• 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: 17484862
• Report Number: 3016525500-2023-00032
• Device Sequence Number: 12732994
• Product Code: QLG
• UDI-Device Identifier: 00850003506357
• UDI-Public: 00850003506357
• 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
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2023

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: 01/31/2023
• Device Model Number: FG-300200
• Device Catalogue Number: FG-300200
• Device Lot Number: 23586
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Unknown