Roche gets FDA clearance, brief recall for diabetes management app

By Jonah Comstock
08:56 am

Roche Accu-Chek ConnectIn March, Roche received FDA clearance for its Accu-Chek Connect companion app, and, less than a month later, issued a recall of that app. App recalls, which are becoming more common as more and more apps receive FDA clearance, are less severe than device recalls because they can often be ameliorated with a quick software patch.

The app, available only on Android at present, helps patients track their blood glucose readings and diabetes symptoms. It received clearance in mid-March. Notably, it includes what Roche says is the first FDA-cleared built-in prescription insulin bolus calculator, called the Bolus Advisor. The app gives people with diabetes a choice of reports to help identify trends and patterns in blood sugar levels and lets them share their data with their caregiver or healthcare team via connected online accounts, email or text message. It receives data from the Accu-Chek Aviva Connect Bluetooth-enabled meter.

"The development of the ACCU-CHEK Connect system underscores Roche Diabetes Care’s commitment to advancing technology that empowers people with diabetes to focus on the daily wins of managing diabetes and living life as normally and actively as possible," a Roche spokesperson told MobiHealthNews in an email. "Long-term diabetes management success isn’t achieved with one sweeping action, but is realized through a series of small victories that help improve overall patient adherence, clinical outcomes and quality of living."

During internal testing, Roche discovered that in Germany, South Africa, and Italy, the app was causing inaccurate bolus advice in situations where the phone orientation changed from portrait to landscape during the calculation, prompting Roche to issue a recall. According to the FDA, the application was only downloaded about 600 times in the affected countries before it was patched.

"The bolus recommendation feature of the app was immediately disabled, and Roche Diabetes Care informed healthcare professionals and users of the ACCU-CHEK Connect diabetes management app in affected countries to be aware of this issue," Roche said. "A new version of the application that contained a fix for the screen rotation issue was made available and the bolus advice was enabled again.  No impacted versions of ACCU-CHEK Connect diabetes management app were released in the U.S."

Earlier this year, AliveCor also had to do a recall for an FDA-cleared app in a similar situation. They also quickly fixed the problem with an update.

Roche is currently working with the FDA to get the iPhone version of the Accu-Chek Connect app approved.


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