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

Model Number FG-300188

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

Patient Problems Hypoglycemia (1912); Cognitive Changes (2551); Confusion/ Disorientation (2553); Convulsion/Seizure (4406)

Event Date 01/23/2023

Event Type  Injury  

Event Description

Customer reported severe hypoglycemic event on (b)(6) 2023.Customer reported a seizure during the event, stating they did not lose consciousness but was not in coherent state.They did not check their blood glucose level on a blood glucose meter, but asked a co-worker to scan the sensor because customer was not able to.The sensor glucose value was reportedly 69 mg/dl, but customer felt it was lower prior to the scan.Customer requested some assistance from the co-worker who provided soda to treat the low glucose conditions.There was no death or permanent impairment associated with the event.

Manufacturer Narrative

Bigfoot conducted a thorough investigation and there was no indication that the product did not meet the 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 and resolved.Therefore, there was no indication that the product did not meet 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.

• 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: 18104222
• MDR Text Key: 327766707
• Report Number: 3016525500-2023-00024
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00850003506258
• UDI-Public: 0100850003506258
• 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: 02/23/2023

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: 04/30/2023
• Device Model Number: FG-300188
• Device Catalogue Number: FG-300188
• Device Lot Number: 25071
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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): Other
• Patient Age: 44 YR