In a recent development, Tandem Diabetes Care has continued to face challenges with its iPhone app linked to the t:slim X2 insulin pump, as some users still report rapid battery depletion issues despite ongoing software updates aimed at resolving the problem. The difficulties persist even after a recall initiated by the company in March and a subsequent software update aimed at addressing the issue.
The t:connect app, designed for use on Apple’s iOS mobile operating system, helps users of the t:slim X2 insulin pump view their blood sugar data and input bolus doses directly from their iPhone. The initial recall and the following software fixes came after multiple user reports indicating that the app caused abnormal battery drainage of the insulin pumps. This faulty operation was suspected to result from the app retrieving excessive data from the pump, leading to increased Bluetooth activity, frequent crashes, and relaunches, which ultimately drained the battery quicker than anticipated.
Despite the deployment of the software update in March, Tandem confirmed that the issue has persisted, with 107 confirmed adverse events linked to the recall reported after the latest update. Compounding the issue, two such instances resulted in injuries requiring hospitalization due to the pump shutting down unexpectedly. The Food and Drug Administration (FDA) also released an alert regarding this on Monday, reflecting the severity of the concern.
Continuing to address this crucial safety concern, Tandem sent out a customer notice on August 9, detailing plans to roll out another software update. This forthcoming update aims to squash any remaining glitches with versions 2.7 and 2.7.1 of the t:connect app. The identified technical malfunction involves the app intermittently pulling significantly more data than required from the insulin pump. Such excess activity not only destabilizes the app, causing frequent crashes and restarts but also leads to premature battery depletion through exacerbated Bluetooth communication. This malfunction risks an unexpected insulin pump shutdown, potentially resulting in an under-delivery of insulin and subsequent hyperglycemia—an acute risk, especially if occurring during nighttime hours.
To mitigate immediate risks while a permanent solution is being developed, Tandem has recommended that users of the affected pumps charge their devices daily for 10 to 15 minutes and ensure the pump is fully charged before bedtime. Moreover, users are advised to immediately charge their insulin pumps following any low-battery alert to prevent any abrupt shutdowns.
This ongoing issue has led to significant safety concerns, with Tandem receiving approximately 224 injury reports over two months linked to app version 2.7 before the latest update. The recall initially issued in March has impacted nearly 86,000 devices across the U.S. As Tandem continues to work on resolving these critical technical problems, the diabetic community affected and the broader healthcare stakeholders await the next update, hoping it will provide a durable fix to ensure the reliability and safety of insulin delivery for users relying on the t:slim X2 pump system.
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