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

Model Number SW-300842, V1.4.5

Device Problems No Audible Prompt/Feedback (2282); Operating System Version or Upgrade Problem (2997); Output Problem (3005); Audible Prompt/Feedback Problem (4020)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer narrative: no complaints or adverse events were reported from the field.Bigfoot is reporting this issue proactively since there is a remote possibility of missing critical alerts.This is an issue introduced by apple ios 15 and later.

Event Description

A bigfoot employee discovered the following scenario: there exists a multiple-fault use case for all ios 15 versions that if the app is in the foreground for a period of greater than five minutes or more (e.G.Disabled lock screen), the modal for notifications will show visually to the user but due to the issue with apple ios 15, the sound and vibration will not annunciate.This case is an issue with apple ios 15 versions and not specific to the bigfoot unity app, where the operating system does not send vibration/sound in the case that a sound/vibe-only notification is triggered when the app is in the foreground.This would manifest if the user were to disable the lock or sleep feature on their phone.There is a remote possibility that this malfunction, if it were to recur, could result in missing a low glucose alert if a patient is not looking at their phone.No complaints from the field have been received as of (b)(6) 2022.

• 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: 14464292
• MDR Text Key: 300349185
• Report Number: 3016525500-2022-00004
• 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: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SW-300842, V1.4.5
• Device Catalogue Number: SW-300842, V1.4.5
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2022
• 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