Error with Tandem insulin pumps causes 700 adverse events, 59 injuries
A line of insulin pumps developed by Tandem Diabetes Care is experiencing a speaker malfunction that triggers an error code disrupting glucose monitoring. In response, the company issued a voluntary medical device correction and promised to develop a software patch.
The problem is limited to t:slim X2 pumps, where an error breaks the link between the insulin delivery mechanism and the glucose monitor, pausing infusions. If left unaddressed, patients may develop hyperglycemia as a result.
Tandem confirmed 700 cases of “adverse events,” primarily involving medically significant high blood sugar, along with 59 injuries linked to the malfunctioning insulin pumps.
No deaths have been reported to either the company or the U.S. Food and Drug Administration (FDA), which issued an alert on Tandem’s behalf.
The error caused by the speaker malfunction can be corrected, and Tandem said it has notified affected customers with instructions on how to resolve it. If the pump stops working due to this issue, it will reportedly display “Malfunction 16.”
A timeline on the software update that will spot the speaker issue and alert the user to a problem preemptively is unknown.
Tandem’s stock has crashed 27% this month, following news of the faulty insulin pumps. The issue was announced on Aug. 7.
Software for t:slim X2 recalled last year
As reported by our sister publication Cardiovascular Business, in May 2024, Tandem issued an update to the t:slim X2 insulin pumps, after a previous iteration caused the pumps to shut down for users on iOS operating systems.
The error, which caused the companion app to repeatedly crash, caused 224 injuries. The FDA issued a Class I alert on behalf of the company, urging users to seek the latest version.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.