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

Model Number FG-300200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Diabetic Ketoacidosis (2364); Loss of consciousness (2418)

Event Date 08/24/2022

Event Type  Injury  

Manufacturer Narrative

No allegation against the system was reported by the customer.Bigfoot conducted a thorough investigation and there was no indication that the product did not meet specification.Bigfoot unity does not include high glucose alerts.Review of the data logs show that the patient was interacting with the system and administering insulin doses.The insulin dose recommendations were reviewed and found to be issued per specification.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 Description

On (b)(6) 2022, a customer reported a severe hyperglycemic event, including loss of consciousness, and dka.Customer was admitted to hospital with blood glucose over 700 mg/dl, treated with insulin drip and injections.Customer was not wearing a sensor at the time of the event and reported having their insulin prescription adjusted just prior to the hospitalization.

• Brand Name: BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM
• Type of Device: 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: 18104217
• MDR Text Key: 327758753
• Report Number: 3016525500-2022-00016
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00850003506357
• UDI-Public: 0100850003506357
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202145
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: FG-300200
• Device Catalogue Number: FG-300200
• Device Lot Number: 14374
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 41 YR