Insulin App Recall Prompts FDA Warning After More Than 200 Reported Injuries

Tandem Diabetes Care, Inc, a medical device manufacturer, has issued a voluntary recall of a mobile insulin management app due to a software malfunction. The glitch has led to more than 200 confirmed injuries and leaves thousands at risk of further harm.

What’s the Issue?

Tandem Diabetes Care has recalled version 2.7 of the Apple iOS t:connect mobile app, a companion app for the company’s t:slim X2 insulin pump with Control-IQ technology. The FDA has identified the recall as Class I—the most serious type of recall—and warned users that the app malfunction could cause serious injuries or death.1

The reason for the recall is a software malfunction that can cause the device to repeatedly crash and restart. This loop drains the insulin pump’s batter faster than usual, which could lead to the pump shutting down unexpectedly. Unexpected pump shutdowns cause interruptions in insulin delivery, putting users as risk of hyperglycemia or diabetic ketoacidosis, due to dysregulation.

As of April 15, 2024, Tandem Diabetes Care has reported 224 injuries associated with the glitch. No reports of death have been made.1

Why it Matters

In response to the software malfunction, Tandem Diabetes Care issued a letter to users urgently advising them to update their mobile app to version 2.7.1 or later.2 However, the nature of the recall—in that it was a correction, rather than a product removal—requires that users receive this communication and heed it on their own. This condition leaves unknowing users at risk of suffering from the glitch.

  • The recall affects both people with diabetes who use the t:slim X2 insulin pump mobile app version 2.7 to self-manage their condition as well as health care providers who may provide care using the same technology.
  • The FDA reported there have been 85,863 app downloads in its tenure,3 emphasizing the need for widespread communication regarding the malfunction.
  • Although Tandem Diabetes Care advised users in a letter that the pump would provide notification prior to shut down, the company warned that users may be at higher risk if the accelerated pump battery is depleted during the night when they are unable to check their alerts.2

Expert Commentary

  • “The purpose of this letter is to advise you that Tandem Diabetes Care is voluntarily correcting the mobile app version 2.7 due to potential crashing resulting in accelerated pump battery depletion. Your safety is our top priority. You are receiving this letter because our records indicate you may be operating t:connect mobile app version 2.7 on the Apple iOS platform with the t:slim X2 insulin pump and you should take actions to update your mobile app version as soon as possible to help mitigate this risk,” warned Tandem Diabetes Care in a letter to users.2
  • “Pump shutdown will cause insulin delivery to suspend, which could lead to an under-delivery of insulin and may result in hyperglycemia or even diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugars and lack of insulin,” said the FDA.1

In-Depth Insights

  • Estimates predict that type 2 diabetes alone will more than double by 2050, from more than 529 million people in 2021 to at least 1.3 billion in 2050.4 The exponential rise in diabetes prevalence across the globe has established the need for versatile diabetes management options among the patient population.
  • The use of mobile health solutions to self-manage diabetes has exploded alongside the proliferation of smartphones in recent years. These applications enable patients to keep track of their physical activity, nutrition, blood glucose monitoring, and even provide self-management interventions and recommendations based on personal data.5
  • A recent report by InsightAce Analytic estimated that during the period of 2023 to 2031, the global diabetes management apps market is forecasted to show a 24.4% compounded annual growth rate.6

Extra Reading

READ MORE: Diabetes Resource Center

References
1. Tandem Diabetes Care, Inc. recalls version 2.7 of the Apple iOS t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology prompted by a software problem leading to pump battery. FDA. News release. May 8, 2024. Accessed May 9, 2024. https://www.fda.gov/medical-devices/medical-device-recalls/tandem-diabetes-care-inc-recalls-version-27-apple-ios-tconnect-mobile-app-used-conjunction-tslim-x2
2. Urgent medical device correction: Mobile app v2.7 crashing resulting in battery pump depletion. Tandem Diabetes Care. Letter. March 26, 2024. Accessed May 9, 2024. https://www.tandemdiabetes.com/docs/default-source/legal/company-update/eb2badb3-5dbd-4b0c-8a38-13fde568e11a-_qsf-0018295_a_mobile_app_v2-7_field_correction_notice.pdf?sfvrsn=2f32c8d7_1
3. Class 1 device recall t:connect mobile app. Data sheet. FDA. May 6, 2024. Accessed May 9, 2024. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=206914
4. Klein H. Diabetes prevalence expected to double globally by 2050. AJMC. June 22, 2023. Accessed May 9, 2024. https://www.ajmc.com/view/diabetes-prevalence-expected-to-double-globally-by-2050
5. Kebede MM, Pischke CR. Popular diabetes apps and the impact of diabetes app use on self-care behaviour: A survey among the digital community of persons with diabetes on social media [published correction appears in Front Endocrinol (Lausanne). 2019 Apr 05;10:220]. Front Endocrinol (Lausanne). 2019;10:135. Published 2019 Mar 1. doi:10.3389/fendo.2019.00135
6. Diabetes management apps market to record an exponential CAGR of 24.4% by 2031 – exclusive report by InsightAce Analytic. News release. PR Newsire. https://finance.yahoo.com/news/diabetes-management-apps-market-record-123400247.html

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