Tandem Diabetes Care (Nasdaq:TNDM) has provided an update on a recall from earlier this year due to a problem with the software of its insulin pump.
In March, the San Diego-based company initiated a recall of version 2.7 of the Apple iOS mobile app t:connect, which is used in conjunction with the t:slim X2 pump with Control-IQ technology.
Tandem has recalled the software version due to an issue that can cause the mobile app to crash and be automatically restarted by the iOS operating system. This cycle repeats periodically, resulting in excessive Bluetooth communication. This can drain the pump battery and potentially cause the pump to shut down sooner than expected.
Pump failure can cause insulin delivery to stop, which can lead to insulin deficiency. This can lead to hyperglycemia or diabetic ketoacidosis, a potentially life-threatening condition due to high blood sugar and insulin deficiency.
In total, the recall affected 85,863 devices in the United States. Tandem reports 107 confirmed adverse events related to the recall. These events resulted in two hospitalizations and zero deaths.
This recall was a correction and not a product removal.
In a new update, Tandem said that some customers continued to experience battery drain issues even after version 2.7.1 was released. The company provided affected customers with updated information and recommendations on how to avoid battery drain on August 9. Tandem now plans to release a new version of the app to address the remaining issues. After the release, the company intends to notify all users via email and app push notifications.
Tandem strongly recommends that affected t:slim X2 users continue to use the pump as described in the user manual. It is recommended that the pump be charged briefly (10-15 minutes) daily to avoid frequent complete battery discharge. Users should monitor the battery level to ensure the pump is fully or nearly fully charged before bedtime to prevent the pump from shutting off. They should also always carry spare supplies, the company recommends.
