United States: More than two hundred and twenty people found themselves hurt due to one of the insulin pump-related app malfunctions, resulting in the attached pumps crashing and losing battery unexpectedly.
What has the FDA said about the incident?
On May 8th, Wednesday, the Food and Drug Administration (FDA) has come out with a class 1 recall alert by Tandem Diabetes Care, Inc, which is the most critical form of product recall, meaning that these item could be life-threatening or have resulted in serious injuries.
The company does so for its app, t: connect, which is used with its t: slim X2 insulin pump.
According to an announcement from the medical device manufacturer, the recall was issued after the t: connect app was having a software problem on Apple iOS devices after their recent system update.
The update resulted in the app crashing and reloading repeatedly, the company confirmed, in a process that caused the attached insulin pumps, which connect to the app through a Bluetooth connection, to experience severe battery drain, as they reloaded over and over again. This caused them to act out of character soon after they started shutting down before the expected time.
FDA stated, “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,” as PEOPLE reported.
As per FDA reports, Around 224 people have experienced injuries after the app crashed. However, no death case has been reported.
The statement from the company
Tandem Diabetes Care made a statement on Thursday, May 9, stating, “This week the FDA posted a Class 1 Recall notification for our t:connect Mobile App iOS v2.7. The t:connect Mobile App is only available in the United States. The recall does not include Android app users.”
It continued, “The correction highlighted in the recall notice was addressed in the t:connect app update for the Apple iOS platform (v2.7.1) released on March 18. Affected customers were notified by Tandem on March 26, and more than 98 percent of affected customers had already updated their devices as of April 15. We continue to make every effort to contact everyone who has not yet updated their iOS app to the new version.”
“Customers using the t:connect Mobile App on the Apple iOS platform can find more information, including how to check the version of the app they are running and how to update the app to v2.7.1, in the notification sent out to affected customers on March 26, 2024,” stated the company, as PEOPLE reported.
Tandem’s statement finally stated, “Ensuring the safety of our patients is our top priority, and we take any safety concerns with our products very seriously. No deaths have been reported, and we will continue monitoring the new version of the t: connect app released in March to ensure the concerns described in the recent recall notice from the FDA have been addressed,”
Know about hyperglycemia or high blood sugar
According to the Mayo Clinic, hyperglycemia or high blood sugar is the stage of high blood sugar where there are missed or insufficient doses of insulin in people with diabetes because their bodies simply do not make enough insulin to control their blood sugar levels.
High blood sugar levels occurs, glucose or blood sugar levels are above 180-200 mg/dL, often due to the fact that you are urinating often, becoming thirsty or getting weak and tired.
The development of diabetic ketoacidosis is the result of a lack of insulin, and this may occur in a diabetic person who does not get enough insulin to his or her body for the generation of its energy, as found in the Cleveland Clinic.
Instead of using insulin, the body will go through its fat stores for energy. Consequently, ketones are released in the body causing the person’s blood to become toxic, with symptoms of abnormally high sugar, nausea, and vomiting, shortness of breath and many others.