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 Hypoglycemia (1912); Dizziness (2194); Cognitive Changes (2551); Confusion/ Disorientation (2553)

Event Date 05/18/2022

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 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 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
• 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: 15034596
• MDR Text Key: 296041975
• Report Number: 3016525500-2022-00008
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00850003506357
• UDI-Public: 00850003506357
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/16/2022
• Initial Date FDA Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2022
• 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: 69 YR
• Patient Sex: Male