08

Apr

2015

Cl II ACCU-CHEK Connect Diabetes Management App

0

Company:Roche Diabetes Care, Inc.
Date of Enforcement Report: 4/8/2015
Class lI:

PRODUCT

ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management. Recall Number Z-1369-2015

REASON
Roche Diabetes Care has become aware of an issue with the Accu-Chek Connect diabetes management app that could potentially lead to inaccurate bolus advice being provided to the user. A thorough investigation of the situation revealed that this issue may occur if the user changes the screen orientation of the phone from portrait to landscape or vise versa while looking at the Bolus Advisor or Carbohydrate Entry screens.

RECALLING FIRM/MANUFACTURER
Roche Diabetes Care, Inc.Indianapolis, IN on 10/30/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
The application has been downloaded total of 644 times (Italy-219, South Africa-24, Germany-401) and there are 113 bolus advice activations.

DISTRIBUTION
There are no US distributors as the affected device is not marketed in the US. The affected device was distributed in Germany, Italy and South Africa. The application has been downloaded total of 644 times (Italy-219, South Africa-24, Germany-401) and there are 113 bolus advice activations.

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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