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U.S. Department of Health and Human Services

Class 2 Device Recall ACCUCHEK Connect Diabetes Management App

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  Class 2 Device Recall ACCUCHEK Connect Diabetes Management App see related information
Date Initiated by Firm October 30, 2014
Date Posted April 02, 2015
Recall Status1 Terminated 3 on June 08, 2015
Recall Number Z-1369-2015
Recall Event ID 70775
510(K)Number K141929  
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product ACCU-CHEK Connect Diabetes Management App; Instruction Manual

Designed to transfer data for diabetes management.
Code Information N/A
Recalling Firm/
Manufacturer		 Roche Diabetes Care, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Anne Gill
317-521-4321
Manufacturer 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
FDA Determined
Cause 2		 Software design
Action 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.
Quantity 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JQP and Original Applicant = ROCHE DIAGNOSTICS CORPORATION
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