FDA Device

ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.

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

What You Should Do

Remedy

Urgent Field Safety Notices were sent to the customer and healthcare professional starting on 10/30/2014. The letter provided a description of the reason for the notification; and recommended that all users should update their app immediately.

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Products

ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.
Brand
Roche Diabetes Care, Inc.
UPC
N/A

Units Affected

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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