The FDA has sent out the largest recall for the insulin pump app.
A Class I recall has been issued by the Food and Drug Administration (FDA) of the United States of America for the t:connect mobile app on iOS. This software is utilized by diabetics to monitor and control the t:slim X2 insulin pump. After receiving approval from the Food and Drug Administration, it was rumored to be the first smartphone app that could program insulin doses. The government agency issued the greatest level of recall it could since the application contained major software flaws that had the potential to result in conditions that may have been fatal or even life-threatening. The Food and Drug Administration (FDA) received 224 injury reports as of April 15, despite the fact that there were no fatalities reported.
According to the agency, the t:connect mobile app version 2.7 contained a fault that caused the app to crash and then be reloaded by the iOS platform multiple times. This cycle continued until the app was finally fixed. It would appear that this resulted in an excessive amount of Bluetooth communication, which ended up draining the battery of the pump and causing it to go down earlier than the user would have anticipated. Insulin pumps, such as the t:slim X2, are designed to provide insulin to the user of the device automatically beneath the skin at predetermined intervals of time and whenever it is required. In order for the user to be able to continue about their day without having to stop and inject themselves or if they are prone to suffering hypoglycemia or hyperglycemia, they are expected to take up the responsibility of regulating the user’s sugar levels.
In the event that a pump suddenly stops working without prior warning and before the user anticipates it to do so, this could result in an inadequate administration of insulin. That might lead to hyperglycemia and even diabetic ketoacidosis, which is a life-threatening issue caused by the inability of the body to convert sugar into energy owing to a lack of insulin, as the Food and Drug Administration (FDA) explained in its recall. During the month of March, Tandem Diabetes Care, the business that is responsible for both the app and the pump, notified all of the clients who were affected by the emergency. It recommended that they keep their app up to date, keep a careful eye on the amount of battery life remaining in their pump, and always carry an extra supply of insulin. The notice of recall issued by the FDA could reach customers who may have been affected by the recall but who may not have received the alerts issued by the manufacturer or who may have considered it irrelevant. There have been several deaths that have been linked to insulin pumps that have malfunctioned in the past; therefore, users may wish to keep a close eye on their own insulin pumps, regardless of the manufacturer.