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	Hyperglycemia (1905)
Date of Event	04/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bigfoot conducted a system review for the time period leading up to the adverse event.During this time, the bigfoot unity system was functioning per specification.Review of the data logs show that the patient was interacting with the system and receiving correction dose recommendations and system alerts.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.Please note that this mdr is being submitted to correct an error in the fei for mdr 301552550002023-0026 which was received by fda on 05-26-2023.
Event or Problem Description
Patient reported that they were hospitalized with bg levels of 1500 mg/dl.Patient reported that their long-acting insulin was changed recently from novolin-n (using vial/syringe) to toujeo (using insulin pen), and they just started using bigfoot unity system.

• 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 ; 4087165600
• MDR Report Key: 17436431
• Report Number: 3016525500-2023-00029
• Device Sequence Number: 6770420
• 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 Expiration Date: 11/30/2023
• Device Model Number: FG-300186
• Device Catalogue Number: FG-300186
• Device Lot Number: 32124
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2023
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female