A pharmaceutical company said Monday that its recalled iOS app and insulin pump has led to several hospitalizations and more than 107 confirmed adverse events, adding that consumers have continued to experience issues after an update. The earlier update was designed to fix the issue that made it crash while the patient is sleeping, draining the battery, and not providing enough insulin through a pump, the firm has said. The under-delivery of insulin due to the reported pump shutdowns “can result in hyperglycemia or diabetic ketoacidosis, which can be a life-threatening condition due to high blood sugar and lack of insulin,” said the update.
The company said that notices were sent to impacted consumers earlier in August and provided “updated information and recommendations for helping avoid pump battery depletion.” A new version of the app is being planned to address the any issues, the firm said, adding that it will notify all users by email and app push notifications following its release. The company did not say when the update will be released.
As of August, there have been 107 adverse events confirmed in connection to the recall, according to Tandem Diabetes. It defined such events as having high blood sugar or an event that requires medical intervention. Meanwhile, two hospitalizations and no deaths were reported.
In the meantime, the company said that anyone using the app and insulin pump to continue using it and charge it for 10 to 15 minutes each day to avoid frequent full battery discharges. Consumers are also advised to monitor the pump before going to sleep to prevent it from shutting down, it said. The company also recommends that people with diabetes carry backup supplies for insulin delivery if the pump fails.
Diabetes can cause health complications including heart disease, kidney failure, stroke, and blindness, as well as a loss of legs, feet, or toes, health officials warn..
