Tandem Diabetes Care to Release Updated iOS t:connect Mobile App for t:slim X2 Insulin Pump Users Impacted by March 2024 Nationwide Recall

Rhea-AI Summary

Tandem Diabetes Care (Nasdaq: TNDM) has announced the release of version 2.8.2 of its Apple iOS t:connect mobile app on August 20, 2024. This update aims to address a battery depletion issue in t:slim X2 insulin pumps, which was the subject of a March 2024 recall. The problem can cause rapid battery drain, leading to unexpected pump shutdowns and potential health risks for users.

Key points:

• 143 confirmed adverse events, including two hospitalizations
• Update available in Apple App Store on August 20, 2024
• Impacted users urged to update their app immediately
• 24/7 technical support available for assistance

Positive

• Proactive release of updated app to address safety concerns
• Additional improvements included to help preserve pump battery life
• 24/7 technical support available for impacted customers

Negative

• 143 confirmed adverse events, including two hospitalizations
• Potential risk of hyperglycemia or diabetic ketoacidosis due to pump shutdowns
• Continued issues after previous app update in March 2024

Medical Device Expert

This update addresses a critical safety issue for Tandem's t:slim X2 insulin pump users. The rapid battery depletion problem, if unresolved, could lead to potentially life-threatening complications such as hyperglycemia or diabetic ketoacidosis. With 143 confirmed adverse events, including two hospitalizations, this is a significant concern. The planned release of version 2.8.2 on August 20, 2024, aims to correct this issue and improve battery preservation. However, the extended timeline between the March 2024 recall and this update raises questions about the company's response time to critical safety issues. This situation may impact user trust and potentially affect Tandem's market position in the competitive insulin pump sector.

Financial Analyst

This recall and subsequent app update could have mixed financial implications for Tandem Diabetes Care. On the negative side, the extended period between the initial recall and the fix may lead to customer dissatisfaction and potential market share loss. The 143 adverse events could also expose the company to legal liabilities. However, the proactive approach in addressing the issue and providing a solution might mitigate some reputational damage. Investors should monitor the company's Q3 and Q4 2024 financial reports for any impact on sales or increased costs related to this recall. The incident highlights the importance of quality control in medical device technology and may prompt increased R&D spending to prevent future issues.

Healthcare Technology Specialist

This situation underscores the complexities and risks associated with connected medical devices. The battery depletion issue persisting after the initial fix (version 2.7.1) highlights the challenges in software-hardware interactions for critical medical devices. It's important for Tandem to ensure robust testing protocols for future updates. The incident may prompt regulatory bodies to scrutinize mobile app integrations with insulin pumps more closely, potentially affecting the entire industry. On a positive note, the ability to address this issue through a software update demonstrates the flexibility of connected devices in resolving problems without physical product recalls. This event may accelerate the development of more sophisticated battery management systems and fail-safe mechanisms in future diabetes management technologies.

SAN DIEGO--(BUSINESS WIRE)-- Tandem Diabetes Care, Inc. (Nasdaq: TNDM) today announced the planned release of version 2.8.2 of its Apple iOS t:connect mobile app in the United States on August 20, 2024 to correct an issue described in a March 2024 recall that can cause rapid depletion of a user’s t:slim X2 insulin pump battery. This battery depletion can result in the pump shutting down sooner than expected, which some customers have continued to see following the release of version 2.7.1 of the app in March. Tandem encourages all impacted t:slim X2 iOS users to update their mobile app as soon as the new version is available in the Apple App Store.

Under-delivery of insulin because of a pump shutdown can result in hyperglycemia or diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugar and lack of insulin. There have been 143 confirmed adverse events with this recall. Adverse events are defined as a confirmed high blood sugar and/or an event requiring medical intervention. Two hospitalizations and no deaths have been reported.

Information for Impacted t:slim X2 Pump Users (U.S. iOS app users only)

Only the t:connect Mobile App on iOS devices is impacted by this issue.

About v2.8.2 of the t:connect Mobile App

• Includes additional improvements including one designed to help preserve pump battery life when the pump charge falls below 20 percent
• Does not require a t:slim X2 insulin pump software update
• Available in the Apple App Store on August 20, 2024

Tandem will email impacted customers with instructions on how to update their mobile devices when the new version of the app is available. Any customers without a valid email address will receive the information by U.S. mail.

Impacted customers in the U.S. with questions about this recall or how to update their mobile devices can contact the Tandem Diabetes Care Technical Support Team 24 hours a day, 7 days a week at techsupport@tandemdiabetes.com or (877) 801-6901.

About Tandem Diabetes Care

Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and sells advanced automated insulin delivery systems that reduce the burden of diabetes management, while creating new possibilities for patients, their loved ones, and healthcare providers. The Company’s pump portfolio features the Tandem Mobi system and the t:slim X2 insulin pump, both of which feature Control-IQ advanced hybrid closed-loop technology. Tandem Diabetes Care is based in San Diego, California. For more information, visit tandemdiabetes.com.

Follow Tandem Diabetes Care on X @tandemdiabetes; use #tslimX2 #TandemMobi and #TandemDiabetes.
Follow Tandem Diabetes Care on Facebook at www.facebook.com/TandemDiabetes.
Follow Tandem Diabetes Care on LinkedIn at https://www.linkedin.com/company/tandemdiabetes.

© 2024 Tandem Diabetes Care, Inc. All rights reserved. Tandem Diabetes Care, the Tandem logo, Control-IQ, t:slim X2, and Tandem Mobi are either registered trademarks or trademarks of Tandem Diabetes Care, Inc. in the United States and/or other countries. All other third-party marks are the property of their respective owners.

Forward-Looking Statement

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. These forward-looking statements relate to, among other things, the Company’s plan to resolve the t:connect iOS mobile app software issue with this software update, including the Company’s ability to resolve the software issue with this software update, the timing of this software update, and the ability to reach all of our customers about this software update. These statements are subject to numerous risks and uncertainties, including our ability to resolve the software issue in this release, or at all; the possibility that the rollout of the software update will be delayed; and the possibility that not every customer will update their software app to this version well as other risks and uncertainties identified in the Company’s most recent Annual report on Form 10-K and its other filings with the Securities and Exchange Commissions. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update or review any forward-looking statement in this press release because of new information, future events or other factors.

Important Safety Information

RX ONLY. Indications for Use: t:slim X2 insulin pump: The t:slim X2 insulin pump with interoperable technology is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in people requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The pump is intended for single patient use. The pump is indicated for use with NovoLog or Humalog U-100 insulin. The pump is indicated for use in individuals 6 years of age and greater. Users of the pump must: be willing and able to use the insulin pump and all other system components in accordance with their respective instructions for use; test blood glucose levels as recommended by their healthcare provider; demonstrate adequate carb-counting skills; maintain sufficient diabetes self-care skills; see healthcare provider(s) regularly; and have adequate vision and/or hearing to recognize all functions of the pump, including alerts. The t:slim X2 pump must be removed before MRI, CT, or diathermy treatment. t:connect mobile app: The feature set available within the t:connect mobile app is dependent on the pump software version and the compatible smartphone’s model and operating system (OS). The Display and Data Upload feature set provides a secondary display of pump and continuous glucose monitoring (CGM) information, including display of your pump alerts and alarms, and enables wireless uploading of pump and CGM data to the Tandem cloud through an internet or wireless data connection. Standard carrier data rates may apply. The Bolus Delivery plus Display and Data Upload feature set additionally allows users to request, stop, and cancel a bolus on the pump from the t:connect mobile app. At least one smartphone security setting must be enabled to utilize the Bolus Delivery feature of the t:connect mobile app. WARNING: Always rely on your pump to make therapy decisions when using a smartphone that is incompatible with the Bolus Delivery feature. PRECAUTIONS: Always rely on your pump to make therapy decisions if using a smartphone that is incompatible, the smartphone is lost or damaged, or the smartphone loses Bluetooth® connectivity with your pump. Important pump alerts and alarms are only received as app notifications when enabled and the app is either active or running in the background. Visit tandemdiabetes.com/safetyinfo for additional important safety information.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240819709224/en/

Media Contact:

858-366-6900

media@tandemdiabetes.com

Investor Contact:

858-366-6900

IR@tandemdiabetes.com

Source: Tandem Diabetes Care, Inc.

FAQ

When will Tandem Diabetes Care (TNDM) release the updated iOS t:connect Mobile App for t:slim X2 insulin pump users?

Tandem Diabetes Care (TNDM) will release version 2.8.2 of the iOS t:connect Mobile App on August 20, 2024.

What issue does the updated t:connect Mobile App for TNDM's t:slim X2 insulin pump address?

The updated app addresses a battery depletion issue that can cause rapid draining of the t:slim X2 insulin pump battery, potentially leading to unexpected pump shutdowns.

How many adverse events have been reported related to the TNDM t:slim X2 insulin pump battery issue?

There have been 143 confirmed adverse events related to the t:slim X2 insulin pump battery issue, including two hospitalizations.

What are the potential health risks associated with the TNDM t:slim X2 insulin pump battery issue?

The battery depletion issue can lead to pump shutdowns, potentially resulting in under-delivery of insulin, which can cause hyperglycemia or diabetic ketoacidosis, a life-threatening condition.