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

Model Number	FG-300185
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypoglycemia (1912); Blurred Vision (2137); Loss of consciousness (2418)
Date of Event	02/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer reported that they did not receive an alert from the bigfoot unity system.They suspect it was because they were too far from their phone.Bigfoot conducted a thorough investigation and there was no indication that the product did not meet specification.Data logs from the patient's unity system were reviewed and showed that there was no ble communication between the sensor and the bigfoot unity mobile app at the time of the hypoglycemic event.The system issued a sensor unavailable alert per specification and the alert was also acknowledged on the patient's phone.The system did not issue a low glucose alert during the period of non-connectivity, per specification.The sensor is not manufactured by bigfoot and the manufacturer of the sensor has been notified of this adverse event.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
A customer experienced symptoms of severe hypoglycemia including blurred vision and loss of consciousness.The customer required emt assistance and evaluation or treatment by an hcp.Two glucose tablets were administered, and, in the ambulance, they were given something to bring their glucose level up (through iv).The customer was admitted to the hospital, monitored, and treated.They were hospitalized for 2 days.There was no report of death or permanent impairment associated with the event.

• 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, CA 95035 ; 4087165600
• MDR Report Key: 13831746
• Report Number: 3016525500-2022-00002
• Device Sequence Number: 13670660
• Product Code: QLG
• UDI-Device Identifier: 00850003506227
• UDI-Public: 00850003506227
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2022

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 Model Number: FG-300185
• Device Catalogue Number: FG-300185
• Device Lot Number: 00000197
• 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: 02/25/2022
• Initial Report FDA Received Date: 03/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male