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	Fatigue (1849); Hyperglycemia (1905)
Date of Event	02/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer narrative: no device issues were reported by the customer.The customer did not know the date the event took place.Bigfoot conducted a thorough investigation and found that the event potentially occurred in february due to the several instances of prolonged high glucose identified.Investigation found that the system performed as intended during this time.Instances of low glucose were also discovered and the system performed as intended and raised low glucose alerts per specification in each instance.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.Justification for delay in submission: bigfoot became aware of the hyperglycemic event on (b)(6) 2022 but upon initial investigation, no device data was found for the month of march, indicating that the customer wasn't using the system at the time.Successful contact with the customer on (b)(6) 2022 indicated that the event potentially happened in the month of april, however, there was also no device data found for the month of april.For completeness, bigfoot extended the investigation to review the last available glucose data in the month of february.Bigfoot was then able to identify a period of potential hyperglycemia taking place in feburary that was consistent with the event described by the customer.
Event or Problem Description
A customer experienced symptoms of severe hyperglycemia including feeling weak when they woke up at approximately 1:00 am est.The customer did not know the date the event took place.They did not check their blood glucose level on a blood glucose meter but the sensor glucose values were above 400mg/dl.They were treated in the emergency room with insulin and iv fluids.There was no report of death or permanent impairment associated with the event.

• 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
• 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: 14528055
• Report Number: 3016525500-2022-00006
• Device Sequence Number: 12217099
• Product Code: QLG
• UDI-Device Identifier: 00850003506258
• UDI-Public: 00850003506258
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2021
• Device Model Number: FG-300188
• Device Catalogue Number: FG-300188
• Device Lot Number: 00000364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2022
• Initial Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• 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: 43 YR
• Patient Sex: Female