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 Codes	Hypoglycemia (1912); Dizziness (2194); Cognitive Changes (2551); Confusion/ Disorientation (2553)
Date of Event	05/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer narrative: no device issues were reported by the customer.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 the system issued low glucose alerts per specification and some alerts were acknowledged by the customer.After acknowledgement or resolution of an alert, the system re-issued low glucose alerts per specification when the customer's glucose reached the low and very low levels.Data logs also showed that the insulin recommendations issued by the system met specifications.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 disorientation and dizziness.The customer needed medical intervention to treat their low glucose condition and were given glucose tablets, iv fluids and monitored in the hospital for several days.The customer stated that they received low glucose alerts from the bigfoot unity system.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: 15034596
• Report Number: 3016525500-2022-00008
• Device Sequence Number: 5060624
• Product Code: QLG
• UDI-Device Identifier: 00850003506357
• UDI-Public: 00850003506357
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2022

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 Expiration Date: 06/30/2022
• Device Model Number: FG-300200
• Device Catalogue Number: FG-300200
• Device Lot Number: 13574
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male