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

Model Number	FG-300188
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypoglycemia (1912); Cognitive Changes (2551); Confusion/ Disorientation (2553); Convulsion/Seizure (4406)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• 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: 18104222
• Report Number: 3016525500-2023-00024
• Device Sequence Number: 14809640
• Product Code: QLG
• UDI-Device Identifier: 00850003506258
• UDI-Public: 0100850003506258
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2023
• Device Model Number: FG-300188
• Device Catalogue Number: FG-300188
• Device Lot Number: 25071
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Sex: Unknown