Tandem Diabetes t:slim X2 Insulin Pump Lawsuit Lawyers

Class I Recall Raises Alarm Over Potential Health Hazards Linked to Software Malfunctions in the X2 Insulin Pump

Tandem Diabetes Care has been grappling with serious software problems concerning its t:slim X2 insulin pump. Earlier this year, the U.S. Food and Drug Administration (FDA) issued a Class I recall—its most severe recall classification—due to concerns related to a malfunction in the pump’s mobile app. The t:slim X2 insulin pump is a critical device used by many diabetic patients to regulate insulin levels. However, repeated issues with its Apple iOS app have put users at risk of experiencing dangerous health complications.

The software malfunction in question causes the app to crash and restart repeatedly, leading to excessive Bluetooth communication between the app and the pump. This persistent cycle results in significant battery drainage, sometimes causing the pump to shut down unexpectedly. The most immediate concern is that when the pump shuts down, it suspends insulin delivery, which can quickly lead to a dangerous under-delivery of insulin. For diabetic patients, this presents a significant risk of hyperglycemia (high blood sugar), and in severe cases, it can escalate to diabetic ketoacidosis, a life-threatening condition caused by a lack of insulin.

When the issue was first brought to light in March 2024, Tandem Diabetes Care urged users to download version 2.7.1 or later of the mobile app to resolve the battery drain issue. Unfortunately, even with the updated version, the problems persisted. As recently as August 2024, Tandem released further notices to customers, explaining that they are working on a new version of the app to address these ongoing issues.

The company provided interim recommendations to users to mitigate the risk. For instance, they advised patients to charge the pump for 10 to 15 minutes every day and to avoid letting the battery deplete completely. They also recommended that users carry backup supplies at all times. The recurring software glitches in the app have led to frequent crashes, resulting in excessive Bluetooth communication between the pump and the app. This activity drains the pump’s battery much faster than expected, potentially causing the pump to shut down prematurely.

When the insulin pump shuts down, insulin delivery is interrupted, putting users at risk for under-delivery of insulin. This, in turn, can lead to dangerous conditions like hyperglycemia (high blood sugar) or diabetic ketoacidosis (DKA), a life-threatening condition that occurs when the body lacks enough insulin. DKA can cause severe complications, including organ failure, coma, or even death if left untreated. For patients dependent on these insulin pumps to regulate their blood sugar, the situation can escalate quickly, making it a significant safety concern.

Tandem Diabetes Care initially addressed the issue by advising users to update to a new version of the mobile app, version 2.7.1. The company assured patients that this update would resolve the battery-draining problem. However, in August 2024, the company admitted that the issue had persisted despite the update. Users continued to experience battery problems, putting them at risk of pump failure. Tandem has since recommended that patients charge their insulin pumps for 10 to 15 minutes daily to avoid full battery depletion. Additionally, users are urged to keep backup supplies with them at all times and charge their devices immediately when receiving a battery warning.

How People Are Harmed by This Defective Product

Patients relying on the t:slim X2 insulin pump have suffered from serious risks due to these ongoing malfunctions. If a patient experiences a pump shutdown without sufficient insulin backup, they may face dangerous spikes in blood sugar levels. Even short periods without insulin can lead to hyperglycemia, with symptoms such as excessive thirst, frequent urination, fatigue, and confusion. If left unaddressed, these symptoms can progress to ketoacidosis, a condition marked by nausea, vomiting, abdominal pain, and shortness of breath. In extreme cases, diabetic ketoacidosis can cause irreversible damage and death.

The impact of a device malfunction extends beyond the physical consequences. Patients may experience heightened anxiety and stress, constantly worrying about whether their insulin pump will fail them when they need it most. These problems also disrupt the daily routines of users, who are forced to carry extra supplies and monitor their pumps more frequently than they should have to, adding an additional burden to managing an already challenging condition.

Filing a Lawsuit and Seeking Compensation for Damages

Patients affected by the t:slim X2 insulin pump malfunction may have grounds to file a product liability lawsuit against Tandem Diabetes Care. In a product liability lawsuit, victims can seek compensation for the harm they suffered as a result of using a defective product. Victims of defective medical devices often face medical expenses, lost wages, and emotional distress due to the injuries they suffer.

The process of filing a lawsuit for product liability typically begins by consulting with a skilled attorney. An attorney can review the facts of the case, gather evidence, and evaluate whether there is a basis for a claim. In cases involving defective medical devices like the t:slim X2 insulin pump, attorneys may work with medical experts to establish that the device was defective and that the defect directly caused the plaintiff’s injuries.

Once a lawsuit is filed, the legal process typically involves investigation and discovery, during which the attorneys on both sides gather evidence and take depositions. The goal is to build a strong case that demonstrates how the defective insulin pump caused harm. In many cases, defective product lawsuits are resolved through settlement negotiations, but some cases may go to trial if a fair settlement cannot be reached.

Why an Attorney Is Essential in This Process

Navigating a product liability lawsuit can be complicated, especially in cases involving medical devices. An attorney with experience in product liability law can help ensure that victims understand their legal rights and options. They can guide clients through every step of the legal process, from investigating the claim to negotiating a settlement or preparing for trial.

In addition to their legal expertise, attorneys can help clients manage the emotional and logistical challenges of a lawsuit. They will handle the complex legal work while allowing victims to focus on their health and well-being. Additionally, attorneys often work on a contingency fee basis, which means clients do not have to pay legal fees upfront. Instead, attorneys are compensated out of any settlement or award they secure for their clients.

Damages That Could Be Recovered in a Product Liability Lawsuit

Victims who file product liability lawsuits for injuries caused by defective insulin pumps like the X2 could recover various types of damages, including:

• Medical Expenses: Compensation for past and future medical bills related to the injuries caused by the defective product, including hospital stays, medications, and ongoing treatment.
• Lost Wages: If the injury caused by the defective product results in time away from work, victims could recover compensation for lost income.
• Pain and Suffering: Victims may be compensated for the physical pain and emotional distress caused by the defective product.
• Punitive Damages: In cases where the manufacturer’s conduct was especially reckless or egregious, punitive damages may be awarded to punish the manufacturer and deter similar conduct in the future.