Accu-Chek Connect Diabetes Management app

Safety advisory - update app to correct programming error

12 September 2016

Consumers and health professionals are advised that Roche Diabetes Care Australia, in consultation with the TGA, is instructing users of the Accu-Chek Connect Diabetes Management app for iOS (Apple devices only), who are using it for bolus injection advice, to immediately download and install the new app version 1.2.2(.2) from the Apple App Store. The updated app will appear as v1.2.2.

Accu-Chek Connect Diabetes Management app is used in conjunction with Accu-Chek Aviva Connect and Accu-Chek Guide blood glucose meters to assist users in receiving bolus insulin advice.

It has been identified that a programming error in the iOS version 1.2.0(.5) of the app could, under certain conditions, potentially lead to incorrect bolus insulin advice being provided to the user.

As a result of the programming error, a blood glucose value that could not be used initially may unintentionally become available for bolus advice calculation at a later time. If the user requests a bolus advice for a blood glucose value older than 10 minutes without taking and transferring a new blood glucose measurement, it can lead to an incorrect bolus insulin recommendation.

If this occurs, it could lead to serious health consequences, such as hypoglycaemia (low blood sugar).

The new app version 1.2.2(.2) corrects this issue. Users will be prompted to download the update in the App Store.

Information for consumers

If you or someone you provide care for, uses the Accu-Chek Connect Diabetes Management app on an iOS Apple device for bolus advice, check which version of the app you are running. To do this: Choose 'Settings', scroll down to find your Accu-Chek Connect App icon then click on it, the version number will be listed under the heading 'About'.

If you are using iOS version 1.2.0(.5), stop using it and immediately download the new app version 1.2.2(.2) from the Apple App Store. The updated app will appear as v1.2.2.

Please note that this issue affects Apple devices only and does not affect users with the Android version of the app.

Roche Diabetes Care Australia is writing to health professionals who are managing patients who use the app, providing further information about this issue. Those health professionals are being asked to contact potentially affected patients to ensure they update their app immediately.

If you have any questions or concerns about this issue, speak to your diabetes nurse educator or other health professional. Alternatively, you can contact Roche Diabetes Care Australia on 1800 251 816.

Information for health professionals

Roche Diabetes Care Australia is writing to health professionals who are managing patients who use the Accu-Chek Connect Diabetes Management app for bolus advice, providing further information about this issue.

If you are treating a patient who may be using the app on an Apple device for bolus advice, advise them of this issue and instruct them to immediately download the new app version 1.2.2(.2) from the Apple App Store.

If you have any questions or concerns about this issue, contact Roche Diabetes Care Australia on 1800 251 816.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.