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Warning Date
    2015-05-26

SFDA Alerts about Inaccurate Recommendations of Accu-Chek® Connect Application for Diabetes Management

2015-05-26

 

 

SFDA alerted users  of Accu-Chek® Connect Application for Diabetes Management on Smart Phones, that the application may give inaccurate recommendations for the  insulin dosage, leading to potential risks to user’s  health when adopting such recommendations.

SFDA clarified in a statement, that this problem occurs when using the application-developed by Roche Diavenostic- from the ‘dosage consultant screen’ or ‘carbohydrates input screen’. When the user changes the position of the smart phone from vertical to horizontal position or vice-versa, the  application will reset the calculated or entered value by the user and change it to vacant. If the user does not notice the change of dosage or carbohydrates value and continued using the application, this will lead to change of recommended dosage to zero and save it instead of the proper value. (see attached  picture)

SFDA advised users to immediately update the Accu-Chek® Connect Application. If the problem occurred again, or the user has any questions about the application, please contact the local distributer Roche  Company for Diabetes Care on toll free number 8002443210 and to be cautious when using such applications and not to fully rely on them without consulting the doctor.

SFDA called users to report any problems of medical devices and products to the national center for medical devices reports, website:

 

 



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