Insulin pumps recalled due to malfunction risk—users warned to update software
The U.S. Food and Drug Administration (FDA) has announced a new recall for the Tandem Mobi Insulin Pump from California-based Tandem Diabetes Care.
The battery-operated Tandem Mobi Insulin Pump can provide users with long-acting basal insulin doses or short-acting bolus insulin doses. It delivers insulin from a disposable cartridge, through an infusion set and into the patient’s tissue.
The recall was put in place due to a possible software malfunction that could interfere with the delivery of insulin. According to the FDA, if this failure occurs, it could result in patients developing hyperglycemia.
Unlike many recalls, this is not a product removal. However, the FDA has still determined this is a Class I recall, which means there is a risk of serious injuries or even death if customers do not follow company recommendations.
This recall covers nearly 18,000 insulin pumps distributed throughout the United States. The devices do not need to be returned, but Tandem Diabetes Care is urging customers to update their pump software immediately. The newest version of the pump software is 7.9.0.2. Customers can use their Tandem Mobi Mobile App to confirm their software version and update it if necessary.
If any customers encounter this specific malfunction and their pump stops working, they are advised to contact Tandem Diabetes Care customer service for assistance. In addition, they should switch to their “backup method of insulin delivery” and regularly check their blood sugar.
Click here for additional details from the FDA.
Previous insulin pump error linked to adverse events
In August, Tandem Diabetes Care issued a medical device correction for certain t:slim X2 insulin pumps due to reports of the devices malfunctioning. The issue was associated with a total of 700 adverse events and 59 injuries. Click here to learn more.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.