The Food and Drug Administration (FDA) of the United States of America recently announced a recall (withdrawn from the market) of the highest level of severity, for a mobile application connected to an insulin pump. The application, the t:connect Mobile App iOS v2.7 from Tandem Diabetes Care, was withdrawn due to a bug that affected its communication with the insulin pump t:slim X2.
This software could put diabetes patients, who rely on the app to control their insulin levels, at serious health risk. The FDA has advised patients to stop using the affected version of the app for the time being, and go back to using the interface of the insulin pump until the problem is solved. The company Tandem Diabetes Care is already fixing the problem and is expected to release a corrected update of the software. Users, meanwhile, were encouraged to monitor their glucose levels closely and to consult their healthcare professionals about managing their insulin.
In the analysis of the problem in question, it was observed that this application - intended to be synchronized with the insulin pump t:slim X2 - stops and restarts abruptly, which can lead to rapid depletion of the pump's battery and users may not be able to access or control it via the app. In these situations, interruptions in insulin administration can occur, posing serious health problems for patients dependent on the pump.
The original article via BaselineMag can be read here.
