Understanding the Impact and Legal Recourse for Affected Users
The FDA has issued a recall statement following reports of injuries linked to the iOS app version 2.7 of t:connect, used with the t:slim X2 insulin pump with Control-IQ technology. This Class I recall, the most serious type issued by the FDA, affects over 86,000 devices in the United States. The recall was prompted by a software issue that causes the app to crash and relaunch repeatedly, leading to excessive Bluetooth communication that drains the insulin pump’s battery, potentially causing it to shut down abruptly.
The Risks Posed by the Defective App
The primary concern with the malfunctioning app is the potential delay in insulin delivery due to the pump’s unexpected shutdown. This can lead to life-threatening conditions such as hyperglycemia, where blood sugar levels become dangerously high, and diabetic ketoacidosis (DKA), a severe complication of diabetes that occurs when the body starts breaking down fats at an alarming rate, producing ketones that make the blood acidic. Both conditions require immediate medical attention and can have long-term health impacts if not promptly addressed.
Users have reported 224 injuries associated with this software issue, underscoring the severity of the problem. The failure of an insulin pump to deliver the necessary dose of insulin can cause a cascade of health issues, emphasizing the critical need for reliable medical devices and software.
The Recall and Immediate Actions
In response to the identified risk, Tandem Diabetes Care Inc. issued a recall and notified affected users, urging them to update their software to version 2.7.1 or later, which is available for download in the Apple App Store. The updated version aims to resolve the issue, preventing the app from crashing and ensuring stable Bluetooth communication.
Users were advised to complete an online form to confirm they had received and acted upon the notice. Additionally, they are encouraged to monitor the pump’s battery level closely and carry backup insulin delivery supplies in case of pump failure. This proactive approach is crucial to manage the risk and ensure continuous insulin delivery.
Legal Recourse for Affected Users
Individuals who have been harmed by the malfunctioning insulin pump app may be entitled to seek compensation through a product liability lawsuit. This type of legal action holds manufacturers accountable for releasing defective products that cause harm. Victims can recover damages for medical expenses, pain and suffering, lost wages, and other related costs.
To file a lawsuit, it is essential to gather evidence showing the connection between the defective app and the injury sustained. This includes medical records, evidence of device usage, and documentation of any adverse events. Consulting with a personal injury attorney who specializes in product liability is a critical first step. They can provide guidance on the legal process, help gather the necessary evidence, and represent the victim in court if required.
The Importance of Legal Representation
Navigating the legal complexities of a product liability lawsuit requires experienced legal representation. An attorney can ensure that all procedural requirements are met and can negotiate with the manufacturer or their insurance company on behalf of the victim. Legal professionals also play a vital role in quantifying the damages, including both economic and non-economic losses, to ensure fair compensation.
Given the potential for severe health impacts from the insulin pump’s malfunction, having a dedicated attorney is crucial. They can help victims understand their rights, the legal process, and the types of compensation available, providing much-needed support during a challenging time.
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