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

Model Number FG-300185

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

Patient Problems Hypoglycemia (1912); Dizziness (2194); Cognitive Changes (2551); Balance Problems (4401)

Event Date 04/23/2022

Event Type  Injury  

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 a low glucose alert per specification and the alert was acknowledged.After initial acknowledgement, the system issued alerts again when the customer's glucose reached the low and very low levels and these alerts resolved 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

A customer experienced symptoms of severe hypoglycemia including lightheadedness, stumbling/falling, feeling lethargic, and having a hard time remembering.The customer required assistance from their step-son who provided some carbohydrates (hamburger steak, salad, and slaw) to treat the low glucose condition.There was no report of death or permanent impairment associated with the event.

• Brand Name: BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM
• Type of Device: 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: 14504418
• MDR Text Key: 292717544
• Report Number: 3016525500-2022-00005
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00850003506227
• UDI-Public: 00850003506227
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2022
• Device Model Number: FG-300185
• Device Catalogue Number: FG-300185
• Device Lot Number: 2590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2021
• 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): Other
• Patient Age: 72 YR
• Patient Sex: Female