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

Model Number	FG-300203
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); No Audible Prompt/Feedback (2282); No Visual Prompts/Feedback (4021); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bigfoot investigation showed that there was no ble communication between the sensor and the bigfoot unity mobile app prior to the alleged event.Data logs also showed that sensor unavailable alerts were turned off and therefore no sensor unavailable alerts were raised, per specification.Bigfoot cannot confirm if the app was stuck on the "bigfoot" screen as alleged by the customer, and the event was resolved by restarting the customer's phone.However, bigfoot identified the possibility that the customer may not receive low glucose alerts if the sensor loses ble communication with the bigfoot unity mobile app during the alleged app condition.Bigfoot data logs indicate that the customer was scanning their sensor via the nfc channel during and prior to the alleged event.The available glucose data from sensor scans indicate that the patient's blood glucose did not drop to low glucose range during this time.
Event or Problem Description
Customer reported that when they try to open the bigfoot unity app, nothing happens and all it displays is "bigfoot".

• Brand Name: BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM
• Common Device Name: DIABETES MANAGEMENT SYSTEM
• Manufacturer (Section D): BIGFOOT BIOMEDICAL,.INC; 1820 mc carthy 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: 18104224
• Report Number: 3016525500-2022-00021
• Device Sequence Number: 17499870
• Product Code: QLG
• UDI-Device Identifier: 00850003506371
• UDI-Public: 00850003506371
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Model Number: FG-300203
• Device Catalogue Number: FG-300203
• Device Lot Number: 17720
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• 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
• Patient Age: 64 YR
• Patient Sex: Unknown