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

Model Number FG-300188

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Hypoglycemia (1912); Dizziness (2194); Shaking/Tremors (2515)

Event Date 06/20/2022

Event Type  Injury  

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.

Event Description

Customer reported a potential severe hypoglycemic event while using bigfoot unity system.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.

Event Description

Customer reported a potential severe hypoglycemic event.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 6th june 2022 to 20th june 2022.Upon follow-up with the customer on 07/05/2022 , the following facts were revealed: customers healthcare provider had lowered their insulin dose to 30 units and customer had been experiencing low blood sugar events overnight.Customer did not lose consciousness during low blood sugar events however, customer felt shaky and woozy.Customer was able to self treat their low blood sugar events with coke and glucose tablets.No third party assistance was required.No allegations were made against bigfoot unity system.

Manufacturer Narrative

No device issues were reported by the customer.Upon follow-up regarding the event with the customer there was no indication that the product did not meet the specification.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 mccarthy 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: 15071332
• MDR Text Key: 296289140
• Report Number: 3016525500-2022-00009
• Device Sequence Number: 1
• Product Code: QLG
• UDI-Device Identifier: 00850003506258
• UDI-Public: 00850003506258
• 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,Followup
• Report Date: 08/19/2022

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: 07/31/2022
• Device Model Number: FG-300188
• Device Catalogue Number: FG-300188
• Device Lot Number: 14031
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 07/05/2022
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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: 59 YR
• Patient Sex: Female