Tandem Diabetes Care to Release Updated iOS t:connect Mobile App for t:slim X2 Insulin Pump Users Impacted by March 2024 Nationwide Recall
2024年8月20日 - 7:30AM
ビジネスワイヤ(英語)
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.
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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
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