Tandem Diabetes Care is facing a formidable obstacle. The company’s iOS app and insulin pump have caused more than 100 medical emergencies this year. This includes two hospitalizations.
The medical device manufacturer recalled 85,863 of its insulin pumps back in May. The move happened after the company identified at least 224 injury reports.
It was later revealed that there was a serious issue with the Tandem Diabetes Care app. The app kept crashing while users slept. This was reportedly due to a software issue. The problem resulted in the pump’s battery draining. This resulted in insufficient insulin delivery from the t:slim X2 pump.
Tandem Diabetes Care promised a March update would fix the issue. The update wasn’t the fix the company hoped. It didn’t solve the problem for some of its users.
The software problem has caused 107 incidents that required medical attention. The company hasn’t disclosed how many happened after they rolled out the update.
Insufficient insulin can cause hyperglycemia or diabetic ketoacidosis. These can become life-threatening conditions due to high blood sugar. It also causes inadequate insulin levels.
The problem is severe enough that the FDA has classified this recall as a Class 1. This is the agency’s most serious category. It highlights the severity of the situation. The FDA also noted that this is the sixth recall for the company’s medical devices.
What Consumers Can Do
Tandem Diabetes Care first alerted users to the issue on March 26.
The company is reportedly developing a new update. It hasn’t provided a release timeline though. Tandem Diabetes Care will notify users once the update is ready. They’ll send an email and push notifications.
Users are also advised to take precautions while waiting for the update.