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); Shaking/Tremors (2515)
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported a potential severe hypoglycemic event.No further information was provided.There was no report of medical intervention, death, or permanent impairment associated with the event.Customer has not provided a date of event to enable further device evaluation, however, potential time of event could have been between (b)(6) 2022 to (b)(6) 2022.
Additional Manufacturer Narrative
All information available to bigfoot has been submitted.A follow-up report will be submitted after bigfoot learns of any new information in relation to this case.Justififcation for delay - bigfoot submitted this report via the (b)(4) on friday (b)(6) 2022 at 01:33:16 edt with a core id (b)(6) and batch id 3016525500-20220804213928, but the report was received to the test database although test (b)(6) account credentials are not accessible.Bigfoot submitted ticket (b)(4) to the esg help desk to determine the cause for this issue.

• Brand Name: BIGFOOT UNITY DIABETES MANAGEMENT SYSTEM
• Common Device Name: DIABETES MANAGEMENT SYSTEM
• Manufacturer (Section D): BIGFOOT BIOMEDICAL, INC; 1820 mccarthy boulevard; milpitas CA 95035
• MDR Report Key: 15429785
• Report Number: 3016525500-2022-00011
• Device Sequence Number: 18087867
• Product Code: QLG
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup

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: 07/31/2022
• Device Model Number: FG-300188
• Device Catalogue Number: FG-300188
• Device Lot Number: 14031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 10/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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: 60 YR
• Patient Sex: Female