Dive Brief:
- Tandem Diabetes Care flagged a problem with certain t:slim X2 insulin pumps where a wiring issue with certain devices’ speakers can cause them to malfunction and stop delivering insulin.
- Tandem said it has received reports of 700 adverse events and 59 injuries. There have been no reports of death. The problem, if not addressed, presents the risk of hyperglycemia in people with diabetes. The company said in a Thursday announcement that it has also alerted the Food and Drug Administration and regulators outside of the U.S.
- The company sent a letter to customers in July. The FDA has not yet posted the device correction in its recall database.
Dive Insight:
Certain types of speakers in Tandem’s devices have a higher risk of malfunction, which can cause insulin delivery to stop and the pump to no longer be operational. The malfunction also stops communication between the pump and the continuous glucose monitor, as well as Tandem’s t:slim mobile app.
Tandem sent letters between July 22 and 24 to people whose devices are at higher risk of the problem, which it refers to as Malfunction 16. The company instructed those people to continue using their devices, “but with added precautions because the Malfunction 16 can occur at any time.”
CEO John Sheridan told investors on Wednesday the company “identified certain speaker versions that have higher-than-normal failure rates” and that the company has not changed its financial expectations as a result of the problem.
In the event of a malfunction, Tandem said users should contact Tandem for a replacement pump and switch to a backup method of insulin delivery. The company said it will release a software update to help with early detection of speaker failure and will add persistent vibration alerts to reduce potential safety risks.
Tandem hasn’t disclosed how many users are affected or the timing of the software update, a company spokesperson told MedTech Dive.
Tandem’s t:slim X2 pump has recently been the subject of two serious recalls. In February, the company notified users about a software defect that could lead to over-delivery or under-delivery of insulin.
Last year, the company recalled a version of its t:connect iPhone app that works with its t:slim X2 device for a fault that could drain insulin pump batteries. Tandem said it received 224 injury reports related to the problem. The company corrected the fault in an app update in March 2024.
