More than 220 people were injured after one brand’s insulin pump app suffered a system failure, resulting in connected pumps malfunctioning and unexpected battery loss.
The Food and Drug Administration (FDA) announced on Wednesday, May 8 that Tandem Diabetes Care, Inc. issued a Class I recall — the most severe form of product recall that states “use of these devices may cause serious injury or death” — for its app, t:connect, which is used with the t:slim X2 insulin pump.
According to an announcement by the medical device maker, the recall was issued after the t:connect app experienced a software issue on Apple iOS devices following a recent software update. The update caused the app to crash and reload, the company said, and attached insulin pumps — which connect to the app via Bluetooth — experienced significant battery drain after the app kept reloading, causing the pumps to shut down sooner than users typically expect. .
“Turning off the pump will cause insulin delivery to stop, which can lead to insufficient insulin delivery and can result in hyperglycemia or even diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugar and lack of insulin,” the FDA said.
According to the FDA, 224 injuries were reported after the app crashed, and there were no deaths.
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On Thursday, May 9, Tandem Diabetes Care released the following statement to PEOPLE:
“This week, the FDA issued a Class 1 recall notice for our t:connect iOS v2.7 mobile app. The t:connect mobile app is only available in the United States. The recall does not include users of the Android app.
“The fix highlighted in the recall notice was addressed in an update to the t:connect app for the Apple iOS platform (v2.7.1) released on March 18. Affected customers were notified by Tandem on March 26, and more than 98% of affected customers have already updated their devices as of April 15th, they are still trying to contact everyone who has not yet updated their iOS app to the new version.
“Customers using the t:connect mobile app on the Apple iOS platform can find more information, including how to check the app version they are running and how to update the app to v2.7.1, in a notice sent to affected customers on March 26, 2024.”
“Ensuring the safety of our patients is our top priority and we take any safety concerns with our products very seriously. There have been no reported deaths and we will continue to monitor the new version of the t:connect app released in March to ensure the concerns described in the recent FDA recall notice are resolved,” concludes Tandem’s statement.
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According to the Mayo Clinic, hyperglycemia, or high blood sugar, occurs in people with diabetes when they miss doses or don’t take enough insulin, since their bodies don’t naturally produce enough insulin to keep their blood sugar under control. High blood sugar usually occurs when a person’s glucose or blood sugar level rises above 180 to 200 milligrams per deciliter, resulting in symptoms such as frequent urination, feeling thirsty, or feeling weak and tired.
Ketoacidosis associated with diabetes can also occur when a person with diabetes does not receive enough insulin to make energy in the body, according to the Cleveland Clinic. Instead of using insulin, the person’s body will begin to break down fat for energy. This releases ketones in the body, which can cause a person’s blood to become acidic, leading to high blood sugar, nausea and vomiting, shortness of breath, and more.
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According to the FDA, 85,000 downloads or updates of version 2.7 of the app were distributed between February 12 and March 13. Tandem advised all its t:connect users to update the app to version 2.7.1 or later using the App Store on Apple devices.
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Tandem said the app, which connects wirelessly to the t:slim X2 glucose monitors and pumps, can adjust a person’s insulin delivery based on readings from the device and can give additional insulin if needed.
Both Tandem and the FDA said that aside from updating the t:connect app, customers using the company’s pumps can continue to use their devices and should always charge their devices after the first low battery warning. Customers should also “always carry a backup supply of insulin in case of insulin pump failure,” the FDA added.
People in the U.S. with questions about the recall can contact Tandem Diabetes Care’s technical support team at (877) 801-6901, according to the FDA.
Categories: Trends
Source: HIS Education