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U.S. Department of Health and Human Services

Class 2 Device Recall AccuChek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android

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  Class 2 Device Recall AccuChek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android see related information
Date Initiated by Firm March 14, 2017
Create Date May 01, 2017
Recall Status1 Terminated 3 on January 16, 2018
Recall Number Z-1899-2017
Recall Event ID 76870
510(K)Number K150910  
Product Classification Calculator, drug dose - Product Code NDC
Product Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android

Product Usage:
This is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads is not available. The number of unique users for each affected version from the date of initial distribution through 03/23/2017 is noted in 7a. However, some users will have used all three affected versions as they upgraded from version to version when the versions became available and many others will have tried the app and discontinued use. In the last 30 days, 02/22/2017 03/23/2017, there have been 16,781 unique users in the US with 264 of those seeking bolus advice and 19,268 unique users in the rest of world (excluding Canada) with 415 of those users seeking bolus advice.
Code Information Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android
Recalling Firm/
Manufacturer		 Roche Diabetes Care, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact Anne Gill
317-521-4312
Manufacturer Reason
for Recall		 A program error (bug) in the Bolus Advisor feature, which could result in incorrect bolus advice and a potential insulin over-delivery.
FDA Determined
Cause 2		 Software design
Action Roche Diabetes Care, Inc. discovered a software issue in the Accu-Chek Connect app versions 2.0.0, 2.0.1, and 2.1.0 that can result in incorrect bolus recommendations. This software bug may result in errors in the active insulin calculation, creating the potential for a false high insulin bolus recommendation. An insulin bolus delivered based on potentially incorrect bolus advice could lead to serious health consequences such as hypoglycemia. Customer notices were distributed via mail on 03/30/2017, and the firm's website was also updated with recall information on that day. Customers were instructed to do the following: discontinue use of the bolus advisor feature in app versions 2.0.0, 2.0.1, and 2.1.0 (iOS & Android) until the corrected version is available. ¿ Provide patients with a copy of the enclosed Urgent Medical Device Correction 17-001. ¿ Complete the enclosed faxback form and fax it to Roche Diabetes Care, Inc., at 1-888-912-8456. ¿ If you have questions about the information in this notification, please contact Accu-Chek Customer Care by visiting accu-chek.com or by calling 1-800-688-4578. The corrected version of the app is expected to be available on or about April 13, 2017. New patients will be able to begin using the bolus advisor feature once the corrected version is available. Please advise your patients to visit accu-chek.com for updates regarding the availability of the corrected version of the app.
Quantity in Commerce 64,324
Distribution US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, DE, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV
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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