Insulin Delivery Problems Lead to Tandem t:slim X2 Insulin Pump Recall: FDA

At least 700 adverse events and nearly 60 injury reports have been linked to a potential speaker issue with the insulin pumps.

Tandem Diabetes Care has recalled select t:slim X2 insulin pumps due to a speaker defect that can trigger an error message and stop insulin delivery.

The U.S. Food and Drug Administration (FDA) announced the t:slim X2 Insulin Pump recall on August 12, after Tandem indicated there had been at least 700 cases of high blood sugar or other medical interventions, as well as 59 reported injuries associated with the pumps.

The t:slim X2 Insulin Pump is a small, wearable insulin pump that is used for managing diabetes. It works as a continuous glucose monitor (CGM), delivering insulin under the skin at either set, or variable rates.

If the pump malfunctions, it may stop delivering insulin, leading to a range of complications, such as low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia), which could result in diabetic ketoacidosis (DKA), potentially causing severe injury or death.

Tandem first announced the device malfunction in a company update issued to customers on July 22, after identifying certain t:slim X2 pumps that may have a wiring issue, causing the speaker to register higher rates of current flowing through the pump. These flow rates may result in a “Malfunction 16” notice from the device, which will lead to the pump immediately shutting down and ceasing insulin delivery.

Customers who receive a Malfunction 16 alert should immediately:

• Silence the alarm
• Contact Tandem for a replacement pump
• Switch to a backup method of insulin delivery

Users who have not received a Malfunction 16 alert can continue using their t:slim X2 pump. However, they should be certain push notifications are turned on in the mobile app, and have a backup delivery method in place in case of malfunction.

Tandem intends to release a software update that allows for early detection of the speaker failure. Pump users will be notified when the update becomes available.

Customers who are unsure whether their pump is affected by the recall can enter the device serial number on Tandem’s website.

Additional questions may be addressed to Tandem Diabetes Care via phone at 1-877-801-6901 or by email at Techsupport@tandemdiabetes.com. Customer support is available 24 hours a day, seven days a week.

Any adverse reactions or other quality problems can be reported to the FDA’s MedWatch Adverse Event Reporting program.

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