Tandem Diabetes Care Warns of Software Problem with Its T:slim X2 Insulin Pumps

San Diego, Calif.-based Tandem Diabetes Care has issued an urgent field safety notice in Europe for its t:slim X2 insulin pumps because of a software problem.

The company said insulin pumps using software installed that is version 6.3.0.1 or lower should upgrade to a newer version, adding that pumps using the Moonlight v7.4 and Carlsbad 6.4 software products are not affected.

The company said the affected software could cause users to “inadvertently program and confirm a basal rate with an incorrectly placed decimal point,” which could lead to an underdose or overdose of insulin.