Tandem Diabetes Care Recalls t:connect Mobile App for Apple Devices

Tandem Diabetes Care, a leading medical device manufacturer, has issued a recall for the t:connect Version 2.7 mobile app designed for Apple devices. The app is used by individuals with diabetes to monitor and control their insulin pump remotely using compatible smartphones.

The t:connect app is specifically designed to work alongside the t:slim X2 insulin pump, which helps manage diabetes by delivering insulin subcutaneously. One of the key features of this pump is its Control-IQ technology, which adjusts insulin delivery based on readings from connected continuous glucose monitors.

The Urgent Medical Device Correction notice was initially issued on March 26, urging customers to update their app to version 2.7.1 or later, available on the Apple App Store. The update was meant to address certain issues with the app.

However, following more than 200 reported incidents of pump shutdown events resulting in injuries, the U.S. Food and Drug Administration (FDA) has classified the recall as Class I. This classification indicates that using the product could pose a serious risk to users’ health, potentially leading to life-threatening injuries or death.

Approximately 85,863 devices distributed in the U.S. between February 12, 2024, and March 13, 2024, are affected by this recall. Tandem Diabetes Care is urging customers to closely monitor their pump battery levels, ensuring that they are fully charged at all times. Patients are advised to charge their devices as soon as they notice low battery levels. Furthermore, users should always carry backup supplies for insulin delivery in case of pump failure.

Tandem Diabetes Care has provided an acknowledgment form for customers to fill out regarding the Mobile App v2.7 Causing Battery Depletion. In case of any queries or concerns related to the recall, customers are encouraged to contact the Tandem Diabetes Care Technical Support Team at (877) 801-6901.

This recall highlights the importance of promptly addressing issues with medical device apps to ensure patient safety. Tandem Diabetes Care is actively working to rectify the situation and minimize any potential risks to users.

FAQ Section:

1. What is the purpose of the t:connect mobile app?
The t:connect mobile app is designed for individuals with diabetes to monitor and control their insulin pump remotely using compatible smartphones.

2. What is the t:connect app specifically designed to work alongside?
The t:connect app is specifically designed to work alongside the t:slim X2 insulin pump, which helps manage diabetes by delivering insulin subcutaneously.

3. What is the key feature of the t:slim X2 insulin pump?
One of the key features of the t:slim X2 insulin pump is its Control-IQ technology, which adjusts insulin delivery based on readings from connected continuous glucose monitors.

4. Why was an urgent medical device correction notice issued?
An urgent medical device correction notice was issued to address certain issues with the t:connect app.

5. Why has the U.S. Food and Drug Administration (FDA) classified the recall as Class I?
The FDA has classified the recall as Class I due to more than 200 reported incidents of pump shutdown events resulting in injuries. This classification indicates that using the product could pose a serious risk to users’ health, potentially leading to life-threatening injuries or death.

6. How many devices are affected by this recall?
Approximately 85,863 devices distributed in the U.S. between February 12, 2024, and March 13, 2024, are affected by this recall.

7. What should customers do to ensure their pump battery levels are fully charged?
Customers are urged to closely monitor their pump battery levels and ensure that they are fully charged at all times. They should charge their devices as soon as they notice low battery levels.

8. What precautionary measure should users take in case of pump failure?
Users should always carry backup supplies for insulin delivery in case of pump failure.

9. How can customers contact the Tandem Diabetes Care Technical Support Team?
Customers can contact the Tandem Diabetes Care Technical Support Team at (877) 801-6901 for any queries or concerns related to the recall.

Definitions:

– Insulin pump: A medical device that is used to deliver insulin continuously to individuals with diabetes.
– Continuous glucose monitor: A device that continuously measures and monitors blood glucose levels in individuals with diabetes.

Suggested Related Links:
Tandem Diabetes Care
FDA Medical Device Recalls