FDA-Device2015-04-08Class II
ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.
Roche Diabetes Care, Inc.
Hazard
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 Carb
Sold states
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.
Affected count
The application has been downloaded total of 644 times (Italy-219, South Africa-24, Germany-401) and there are 113 bolus advice activations.
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1369-2015Don't want to check this manually?
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