- Reaction score
- 1,732
The recall underscores the FDA's challenge in keeping pace with innovation in healthcare technology. While criticisms regarding the agency's slow processes are common, recent efforts indicate a commitment to enhance oversight of healthcare tech. This includes organizational changes within the Office of Strategic Partnerships and Technology Innovation. Yet, the question remains: Can new bureaucratic measures effectively address the FDA's shortcomings?
The US Food and Drug Administration has issued a Class 1 recall for an iOS app that interfaces with an insulin pump due to a software glitch causing the app to crash and automatically restart. This intermittent malfunction drains the pump's battery and may lead to premature shutdown. Such a shutdown halts insulin delivery, posing risks of hyperglycemia or diabetic ketoacidosis.
As of April 15, 2024, there have been no reported deaths, but 224 individuals have reported injuries. A Class 1 recall, the most severe, is initiated when injuries or fatalities are possible, as per the FDA's classification system.
The affected product, the t:slim X2 Insulin Pump Mobile App version 2.7, is manufactured by Tandem Diabetes Care. The company has issued a recall and advises customers to update to version 2.7.1 or later. The recalled version of the app was distributed between February 12 and March 13, 2024, affecting 85,863 devices in the US.
Healthcare apps for mobile devices and smartphones have become commonplace, with new applications released regularly.
www.techspot.com
The US Food and Drug Administration has issued a Class 1 recall for an iOS app that interfaces with an insulin pump due to a software glitch causing the app to crash and automatically restart. This intermittent malfunction drains the pump's battery and may lead to premature shutdown. Such a shutdown halts insulin delivery, posing risks of hyperglycemia or diabetic ketoacidosis.
As of April 15, 2024, there have been no reported deaths, but 224 individuals have reported injuries. A Class 1 recall, the most severe, is initiated when injuries or fatalities are possible, as per the FDA's classification system.
The affected product, the t:slim X2 Insulin Pump Mobile App version 2.7, is manufactured by Tandem Diabetes Care. The company has issued a recall and advises customers to update to version 2.7.1 or later. The recalled version of the app was distributed between February 12 and March 13, 2024, affecting 85,863 devices in the US.
Healthcare apps for mobile devices and smartphones have become commonplace, with new applications released regularly.
FDA recalls faulty iOS app that injured hundreds of insulin pump users
The US Food and Drug Administration has issued a Class 1 recall for an iOS app that interfaces with an insulin pump due to a software glitch...
www.techspot.com
