SAN DIEGO, August 12, 2024–(BUSINESS WIRE)–Tandem Diabetes Care, Inc. (Nasdaq: TNDM) today provided an update on the March 2024 recall of its Apple iOS t:connect mobile app in the United States. The recall relates to an issue that may cause rapid battery drain on a user’s t:slim X2 insulin pump. This battery drain may cause the pump to shut down sooner than expected, which some customers are still experiencing even after the March release of version 2.7.1 of the app. On August 9, 2024, email notifications were sent to affected customers with updated information and recommendations to avoid pump battery drain. Tandem plans to release a new version of the app to address the remaining issues and will notify all users via email and app push notifications following release.
Under-delivery of insulin due to pump failure can result in hyperglycemia or diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugar and insulin deficiency. 107 adverse events have been confirmed in connection 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.
Recommendations for affected users of the t:slim X2 pump
Tandem strongly recommends that anyone using the Apple iOS t:connect mobile app with the at:slim X2 insulin pump do the following:
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Continue to use your tandem pump and the t:connect mobile app as described in the user manual:
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Charge the pump briefly (10 to 15 minutes) every day to avoid frequent complete discharge of the battery.
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Closely monitor the pump’s battery level to ensure that the pump is fully or nearly fully charged before going into sleep mode. This will help prevent the pump from shutting down.
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Always carry spare supplies with you.
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If you receive a low battery warning, Tandem strongly recommends that you charge your device as soon as possible.
A copy of the August 9, 2024 customer notification can be found at tandemdiabetes.com/docs/battery-depletion.
Affected customers in the U.S. with questions about this recall may contact Tandem Diabetes Care’s technical support team 24 hours a day, seven days a week at [email protected] or (877) 801-6901.
About Tandem Diabetes Care
Tandem Diabetes Care, a global insulin delivery and diabetes technology company, manufactures and markets advanced automated insulin delivery systems that reduce the burden of diabetes care while creating new opportunities for patients, their families and healthcare providers. The company’s pump portfolio includes 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.
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© 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 trademarks are the property of their respective owners.
Forward-looking statements
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 address 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 software issue with the t:connect iOS mobile app with a future software update, including the Company’s ability to resolve the software issue with that software update, the timing of that software update and the ability to reach all of our customers through that software update. These statements are subject to numerous risks and uncertainties, including our ability to resolve the software issue in that release or at all; the possibility that the launch of that software update may be delayed; and the possibility that not every customer will upgrade their software app to this version, as 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 Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise any forward-looking statements in this press release as a result of new information, future events or other factors.
Important safety information
RX ONLY. Indications: t:slim X2 insulin pump: The t:slim X2 insulin pump with interoperable technology is intended for the subcutaneous administration of insulin at fixed and variable rates for the treatment of diabetes mellitus in insulin-dependent individuals. The pump can communicate reliably and safely with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from those devices. The pump is intended for single patient use. The pump is intended for use with NovoLog or Humalog U-100 insulin. The pump is intended for use in individuals 6 years of age and older. Users of the pump must: be willing and able to use the insulin pump and all other system components according to the respective instructions for use; test blood glucose levels as recommended by their physician; have adequate carbohydrate counting skills; maintain adequate diabetes self-management skills; regularly consult with healthcare providers; and have sufficient vision and/or hearing to recognize all functions of the pump, including alerts. The t:slim X2 pump must be removed before an MRI, CT or diathermy treatment. t:connect Mobile App: The range of functions available in the t:connect Mobile App depends on the software version of the pump and the model and operating system of the compatible smartphone. Display and data upload The feature set provides a secondary display of pump and continuous glucose monitoring (CGM) information, including viewing your pump alerts and alarms, and allows wireless upload of pump and CGM data to the Tandem Cloud using an Internet or wireless data connection. Standard carrier data rates may apply. The Bolus delivery plus display and data upload The feature set additionally allows users to request, stop, and cancel a bolus on the pump through the t:connect app. To use the bolus delivery feature of the t:connect app, at least one smartphone safety setting must be enabled. WARNING: Always rely on your pump for therapy decisions if you are using a smartphone that is incompatible with the bolus delivery feature. PRECAUTIONS: Always rely on your pump for therapy decisions if you are 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 will only be received as app notifications if they are enabled and the app is either active or running in the background. For more important safety information, visit tandemdiabetes.com/safetyinfo.
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