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

Model Number	FG-300186
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	05/03/2023
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.Please note that this mdr is being submitted to correct an error in the fei for mdr 30155255000-2023-0027 which was received by fda on 06-01-2023.
Event or Problem Description
Patient reported that they had experienced a severe hypoglycemic event during the previous two weeks.No further information was provided.Multiple attempts to collect additional information 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, INCL; 1820 mccarthy boulevard; milpitas CA 95035
• Manufacturer Contact: kate lee ; 1820 mccarthy boulevard; milpitas, CA 95035 ; 4087165600
• MDR Report Key: 17438516
• Report Number: 3016525500-2023-00030
• Device Sequence Number: 6770478
• Product Code: QLG
• UDI-Device Identifier: 00850003506234
• UDI-Public: 00850003506234
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/01/2023

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-300186
• Device Catalogue Number: FG-300186
• Device Lot Number: 30769
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• 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: 53 YR
• Patient Sex: Male