Tandem Diabetes Care's iOS app and insulin pump has made more than 100 people need medical care, resulting in two hospitalizations this year so far.
Tandem Diabetes recalled 85,863 devices in May and said at the time there were at least 224 injuries, promising an update in March would fix an issue that made the app repeatedly crash while diabetics sleep, draining the battery and underdelivering insulin through the :slim X2 pump it connects with via Bluetooth.
But the March update didn't fix the deadly problem for some users.
There have been 107 events requiring medical intervention and the company didn't say how many happened since the March update, Tandem Diabetes said Tuesday.
Underdelivery of insulin can result in hyperglycemia or diabetic ketoacidosis, which can be life threatening because of high blood sugar and lack of insulin.
The U.S. Food and Drug Administration has listed the Tandem Diabetes recall under its most serious classification.
This is Tandem Diabetes Cares's sixth recall for its medical devices, according to the FDA.
Tandem Diabetes Care first warned of the danger in a letter on March 26.
What to do
Tandem Diabetes is working on a new update, but didn't say when it was expected. The company will notify all users when the update is ready via email and a push notification.
Until then, the company said users who continue to use the app and pump should take these precautions:
- Charge the pump for 10 to 15 minutes every day to avoid battery discharges.
- Check battery levels to ensure the pump is at near or full charge before going to sleep.
- Carry back-up supplies.