Tandem Diabetes Care (Nasdaq:TNDM) provided an update on a recall from earlier this year related to an issue with its insulin pump software.
In March, the San Diego-based company initiated a recall of Version 2.7 of the Apple iOS t:connect mobile app used in conjunction with the t:slim X2 pump with Control-IQ technology.
Tandem recalled the software version because of an issue that may cause the mobile app to crash and be automatically relaunched by the iOS operating system. This cycle intermittently repeats, which leads to excessive Bluetooth communication. That may result in pump battery drain, potentially leading to the pump shutting down sooner than typically expected.
Pump shutdown could cause insulin delivery to suspend, which may lead to an under-delivery of insulin. That, in turn, could result in hyperglycemia or diabetic ketoacidosis, a potentially life-threatening condition due to high blood sugars and lack of insulin.
In total, the recall extended to 85,863 devices in the U.S. Tandem reports 107 confirmed adverse events associated with the recall. Those events led to two hospitalizations and zero deaths.
This recall constituted a correction, not a product removal.
In a new update, Tandem said some customers continued to experience the battery depletion following the release of Version 2.7.1. The company issued updated information to impacted customers on Aug. 9 and provided recommendations for avoiding battery depletion. Tandem now plans to release a new version of the app to address the remaining issues. It intends to notify all users by email and app push notifications following the release.
For impacted t:slim X2 users, Tandem strongly recommends continued use as described in its user guide. It calls for a short charging period for the pump (10-15 minutes) every day to avoid frequent full battery discharges. Users should monitor battery levels to ensure the pump is at or near full charge before going to sleep to prevent pump shutdown. They should also always carry backup supplies, the company says.
