Malfunctioning Insulin Pumps Recalled After Multiple Injuries

Authored by Naveen Athrappully via The Epoch Times (emphasis ours),

San Diego-based Tandem Diabetes Care, Inc. agreed to voluntarily recall insulin pumps used to manage blood sugar, the company said in an Aug. 12 announcement by the Food and Drug Administration.

Insulin pumps are wearable devices that deliver insulin at predetermined doses at specific times. Such devices can feature alarm functions to alert users about various situations, such as issues with insulin delivery.

The recalled product, the t:slim X2 insulin pump, is being withdrawn to “address a potential speaker-related issue that can trigger an error resulting in a discontinuation of insulin delivery,” the announcement reads.

“The error, which appears as a Malfunction 16 alarm to the user, will stop insulin delivery and terminate communication between the insulin pump and the continuous glucose monitoring (CGM) device,” it reads.

Continuous glucose monitoring devices constantly track a user’s glucose levels, sending the information to devices such as cell phones, allowing for real-time monitoring of glucose levels.

The malfunction could result in hyperglycemia—high blood sugar—due to the insulin delivery being discontinued and other factors, the company said.

According to the announcement, Tandem has already received 700 confirmed adverse event reports involving high blood sugar and situations that required users to seek medical intervention. Although no deaths have been reported, there have been 59 injuries, it said.

Tandem said it has already informed impacted U.S. customers about the issue through a notice sent between July 22 and July 24.

The notice listed several actions users can take to deal with the malfunction, including preparing a backup method of insulin delivery. It asked users to regularly check their blood sugar levels to ensure they do not have any unexpected high or low readings.

In the Aug. 12 announcement, Tandem said that it will be “releasing a software update designed to enhance early detection of speaker failure.”

“This update will also introduce persistent vibration alerts to help reduce potential safety risk,” it stated.

“Tandem will notify all pump users when the software update becomes available, and to request pump users complete the update of their insulin pump.”

Users can verify whether their insulin pump is included in the recall by entering the device’s serial number on the Tandem website.

Customers with queries can contact the company at 877-801-6901.

Tandem did not respond to a request for comment.

350,000 Insulin Pump Users

Tandem had issued a separate recall of its t:slim X2 insulin pump in February this year, according to FDA data.

That recall was tied to a software defect that could lead to insulin being under-delivered or over-delivered, thus resulting in “severe cases of hypoglycemia or hyperglycemia,” the FDA said.

The recall status is still listed as “open,” according to the agency, indicating the company has not corrected or removed all faulty products.

According to a June 2022 study, there are an estimated 350,000 insulin pump users in the United States. However, they account for only a small portion of people with diabetes.

About 38 million American adults are estimated to have diabetes, and one out of five people are unaware that they have it, the Centers for Disease Control and Prevention said in a May 2024 post.

“In the United States, about 1 in 3 adults has prediabetes. More than 8 in 10 people with prediabetes don’t know they have it,” it said.

“With prediabetes, blood sugar levels are higher than normal, but not high enough for a type 2 diabetes diagnosis. Prediabetes raises your risk for type 2 diabetes, heart disease, and stroke,” the CDC stated.

“Prediabetes and type 2 diabetes can be prevented with lifestyle changes. Currently, no one knows how to prevent type 1 diabetes.”

According to the agency, diabetes is the eighth leading cause of death and the No. 1 cause of adult blindness, lower-limb amputations, and kidney failure.