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Software Issue Leads to Recall of t:connect iPhone App and t:slim X2 Insulin Pump
An incident involving the malfunction of an iPhone app named t:connect has led to injuries suffered by 224 individuals due to the depletion of the battery of its associated insulin delivery device, the t:slim X2 pump. The United States Food and Drug Administration (FDA) has taken swift action in response to this critical situation and issued a Class I recall of the app, marking it as the most severe category of recall by the regulatory body.
The primary reason behind the recall stems from a critical software flaw within the app, which renders it prone to unexpected crashes that consequently prompt the iOS operating system to automatically relaunch the application. Amidst this cycle of instability, an excessive level of Bluetooth activity occurs, significantly accelerating the drain on the pump’s battery, ultimately leading to premature shutdown of the vital insulin delivery device.
Precautionary Measures Urged by FDA
The FDA underscored the importance of vigilant monitoring of the battery status of the pump by consumers, advising them to ensure that it remains adequately charged before bedtime to mitigate the potential risk of pump shutdown. The distressing issue was observed to manifest predominantly between February 12, 2024, and March 13, however, a remedial update has been released to address the persistent problem. Consumers are strongly advised to promptly implement the update to version 2.7.1 or newer of the mobile app. Individuals can identify their current app version by navigating to the “Settings” menu and selecting the “About” tab.
In the absence of proactive measures, the severe consequence of pump shutdown translates to the suspension of insulin delivery, jeopardizing the affected individuals with the prospect of suboptimal insulin intake leading to the development of hyperglycemia or even diabetic ketoacidosis, posing a formidable risk to life due to elevated blood glucose levels and insufficient insulin supply.
Customer Outreach and Support
Tandem Diabetes Care Inc., the manufacturer of the insulin pump and app, has launched an outreach campaign to promptly notify its customer base of the recall. Customers located within the United States who require further clarification or assistance are encouraged to directly contact the company at the dedicated hotline (877) 801-6901, ensuring seamless communication and support provision to address any emerging concerns or queries.
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