Over 200 People with Diabetes Injured After Insulin Pump App Crashes, Drains Battery
The FDA has issued a recall for the t:connect app, which connects via Bluetooth to insulin pumps
Matt Harbicht/Getty
Woman holding a smartphone and an illuminated insulin pump (stock photo)More than 220 people have been injured after one brand's insulin pump app suffered from a system failure, resulting in the attached pumps crashing and losing battery unexpectedly.
The Food and Drug Administration (FDA) announced on Wednesday, May 8 that the company Tandem Diabetes Care, Inc. had issued a Class I recall — the most severe form of product recall that states "use of these devices may cause serious injuries or death" — for its app, t:connect, which is used with its t:slim X2 insulin pump.
According to an announcement from the medical device manufacturer, the recall was issued after the t:connect app experienced a software issue on Apple iOS devices after a recent software update. The update caused the app to crash and reload repeatedly, the company said, and the attached insulin pumps — which connect to the app via Bluetooth — experienced significant battery drain after the app reloaded over and over again, leading the pumps to shut down sooner than users usually expected.
"Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia or even diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugars and lack of insulin," the FDA said.
According to the FDA, there were 224 injuries reported after the app crashed, and no deaths.
On Thursday, May 9, Tandem Diabetes Care released the following statement released to PEOPLE:
"This week the FDA posted a Class 1 Recall notification for our t:connect Mobile App iOS v2.7. The t:connect Mobile App is only available in the United States. The recall does not include Android app users.
"The correction highlighted in the recall notice was addressed in the t:connect app update for the Apple iOS platform (v2.7.1) released on March 18th. Affected customers were notified by Tandem on March 26th, and more than 98% of affected customers had already updated their devices as of April 15th. We continue to make every effort 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 version of the app they are running and how to update the app to v2.7.1, in the notification sent out 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. No deaths have been reported, and we will continue monitoring the new version of the t:connect app released in March to ensure the concerns described in the recent recall notice from the FDA have been addressed," Tandem's statement concluded.
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Per the Mayo Clinic, hyperglycemia, or high blood sugar, occurs in people with diabetes when they miss doses or do not take enough insulin, as their bodies do not naturally produce enough insulin to keep their blood sugar levels under control. High blood sugar usually occurs when a person's glucose, or blood sugar levels, rise above 180 to 200 milligrams per deciliter, resulting in symptoms such as frequent urination, becoming thirsty or becoming weak and tired.
Diabetes-related ketoacidosis can also occur when a person with diabetes does not receive enough insulin to generate energy in the body, according to the Cleveland Clinic. Instead of using insulin, a 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 from Feb. 12 to March 13. Tandem advised all of 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 that the app, which wirelessly connects with the t:slim X2's glucose monitors and pumps, can adjust a person's insulin delivery based on readings from the device, and can give extra insulin if needed.
Both Tandem and the FDA said that other than updating the t:connect app, customers using the company's pumps can continue to use their devices, and should always charge their device after the first low battery alert. Customers should also "always carry backup supplies for insulin delivery in the case of insulin pump failure," the FDA added.
People in the U.S. who have questions about the recall can contact Tandem Diabetes Care Technical Support Team at (877) 801-6901, per the FDA.
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