ACCU-CHEK Connect Diabetes Management App; Instruction Manual Designed to transfer data for diabetes management.
FDA device recall Z-1369-2015 · posted 2015-04-02 · Terminated
Recall details
- Recalling firm
- Roche Diabetes Care, Inc.
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 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
- Date initiated
- 2014-10-30
- Date posted
- 2015-04-02
- Date terminated
- 2015-06-08
- Location
- Indianapolis, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCU-CHEK CONNECT DIABETES MANAGEMENT APP (K141929) | Roche Diagnostics Corporation | 2015-03-16 |