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

Model Number SW-300842, V1.5.2

Device Problems No Audible Prompt/Feedback (2282); Output Problem (3005); Audible Prompt/Feedback Problem (4020)

Patient Problem Insufficient Information (4580)

Event Date 03/20/2022

Event Type  malfunction  

Event Description

A bigfoot employee became aware of the following while reviewing data logs: when a customer re-paired their rapid acting insulin pen cap to the bigfoot unity mobile app, the sensor that was already paired to the mobile app disconnected from the system and did not issue critical alerts.There is evidence that the mobile app displayed a "glucose alerts unavailable.Start new sensor" message to the patient, but since no vibratory or audible "sensor unavailable" alerts were issued after the disconnection, the product did not function as intended.However, valid glucose values were available to the patient every time they scanned the sensor with their pen cap.Evaluation of their glucose data showed that the patient did not enter the 'low glucose' range while the sensor was disconnected from the bigfoot unity mobile app and there is no indication that an adverse event occurred in this instance.

Manufacturer Narrative

No complaints or adverse events were reported from the field.Bigfoot is reporting this issue proactively since critical alerts were not issued to this patient.

• 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 mccarthy boulevard; milpitas CA 95035
• Manufacturer Contact: kate lee ; 1820 mccarthy boulevard; milpitas, CA 95035 ; 4087165600
• MDR Report Key: 14812542
• MDR Text Key: 302807119
• Report Number: 3016525500-2022-00007
• Device Sequence Number: 1
• Product Code: QLG
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SW-300842, V1.5.2
• Device Catalogue Number: SW-300842, V1.5.2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2022
• 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 Age: 56 YR
• Patient Sex: Male