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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 June 08, 2017
Create Date December 06, 2017
Recall Status1 Terminated 3 on August 06, 2018
Recall Number Z-0197-2018
Recall Event ID 77635
510(K)Number K150910  
Product Classification Calculator, drug dose - Product Code NDC
Product Accu-Chek Connect diabetes management software app, Catalog number 07562462001 / GTIN number 00365702700000, Catalog number 07250452001 / GTIN number 00365702700017
The Accu-Chek Connect Diabetes Management App is indicated as an aid in the treatment of diabetes. The software provides for electronic download of blood glucose meters, manual data entry, storage, display, transfer, and self-managing of blood glucose and other related health indicators which can be shown in report and graphical format. The Accu-Chek Bolus Advisor, as a component of the Accu-Chek Connect Diabetes Management App, is indicated for the management of diabetes by calculating an insulin dose or carbohydrate intake based on user-entered data
Code Information Software Versions 1.0.5, 1.0.15, 1.2.0, 1.2.2, 1.2.3, 2.0.0, 2.0.1, 2.1.0, and 2.1.1 for iOS and Android.
Recalling Firm/
Manufacturer		 Roche Diabetes Care, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
Manufacturer Reason
for Recall		 Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. After pairing a meter with the app for the first time, a customer may encounter the rare condition in which the countdown timer is not displayed and correction bolus advice is not available for the most recent, valid glucose reading. This same blood glucose value may become available for bolus advice calculation at a later time (countdown timer is displayed).
FDA Determined
Cause 2		 Software design
Action Roche Diabetes Care sent an Urgent Medical Device Correction letter dated June 12, 2017, to all affected customers. The potential for inaccurate bolus insulin advice can only be encountered if the blood glucose meter has displayed a single E-10 Time/Date error message and the meter had blood glucose records in My Diary and then the meter is pared for the first time with the Accu-Chek Connect App. A customer encountering this issue may find the app does not display the bolus advice option and, consequently, correction bolus advice is not available on the most recent, valid glucose reading. This blood glucose value that could not be used initially may become available for bolus advice calculation at a later time. If the app provides the bolus advice option more than 15 minutes after you tested, it could lead to an incorrect bolus insulin recommendation that should not be used. To completely avoid the possibility of this issue occurring, it is important for Accu-Chek Connect app users to follow the following directions when pairing a meter with the app for the first time: Clear all data from your Accu-Chek blood glucose meter following the steps below, before pairing with the Accu-Chek Connect app for the first time. This clearing of the records in the memory can be accomplished on your PC or Mac by using Accu-Chek Connect Device Link. A micro-USB cable and an Accu-Chek Connect Online account are required. Also ensure that the date and time are set correctly on your blood glucose meter before pairing with the app. Failure to follow these directions might impact first time use of the apps Bolus Advisor feature. Steps to clear data from your Accu-Chek meter in Connect Online: 1. Create or login to your Connect Online account on your PC or Mac. 2. Download Accu-Chek Device Link 3. Right-click on Device Link icon in system tray or dock. 4. Select Settings >Prompt after every successful upload under the Delete Patient Results from Device heading. 5. Connect y
Quantity in Commerce 1,134 bolus advisor features used
Distribution Worldwide Distribution - US (Nationwide) and Canada
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 = NDC and Original Applicant = ROCHE DIABETES CARE INC.
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