Important points
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IOS apps used in conjunction with t:slim X2 insulin pump with Control-IQ may malfunction
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So far, there have been 224 reports of injuries caused when the app drained pump batteries and put users at risk.
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FDA said users should update the app and monitor pump functionality
THURSDAY, May 9, 2024 (HealthDay News) — The U.S. Food and Drug Administration has issued a Class 1 recall (the most urgent type) for IOS apps linked to certain types of insulin pumps used by diabetics. was issued.
The recall notice, which the FDA says is a “correction” rather than a product removal, involves version 2.7 of the Apple iOS t:connect mobile app. Used in conjunction with the t:slim X2 insulin pump with Control-IQ technology.
Issue: Your app may repeatedly crash and restart. Over time, this drains the batteries in the insulin pumps that patients need to function to stay healthy. Nearly 86,000 apps have already been recalled due to this issue.
“Stopping the pump pauses insulin delivery, potentially resulting in insufficient insulin delivery, which can lead to hyperglycemia and even diabetic ketoacidosis, which can be life-threatening due to hyperglycemia and insulin deficiency.” ''The FDA said in a statement Thursday.
So far, authorities are aware of 224 injuries reported as of April 15th, but no fatalities.
Anyone using the t:slim X2 insulin pump mobile app version 2.7 on the Apple iOS platform may be affected.
According to an FDA notice, Tandem Diabetes Care, Inc. has recalled version 2.7 of its t:connect mobile app, which was first released on the Apple iOS platform on February 12, 2024. This app works in conjunction with t:slim X2. Insulin pump. It delivers insulin under the skin at specific but varying rates.
Tandem is urging users to update their software to version 2.7.1 or later. Available on the Apple App Store.
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To check the software version of the t:connect mobile app, open the app and look on your iPhone screen.[設定]Click on the icon and[バージョン情報]Click.
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To acknowledge receipt of this notice, please complete the External Link Disclaimer online form.
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Continue to use the pump as described in the user guide, being aware of all system alerts and alarms.
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Carefully monitor your pump's battery level and make sure your pump is at or near full charge before bed to prevent pump shutdown.
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Start charging your device after the first low battery alert.
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Always carry backup supplies for insulin injections in case your insulin pump breaks down.
If you are a U.S. customer and have questions, please contact the Tandem Diabetes Care technical support team at 877-801-6901.
Source: U.S. Food and Drug Administration, Statement, May 9, 2024
what this means for you
FDA warns users of the t:slim X2 insulin pump that the app used to calibrate the device may be malfunctioning and should be reviewed and updated as necessary to avoid injury. He warns.