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.
- Company
- Roche Diabetes Care, Inc.
- Recall Initiated
- March 14, 2017
- Terminated
- January 16, 2018
- Recall Number
- Z-1899-2017
- Quantity
- 64,324
- Firm Location
- Indianapolis, IN
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.
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
Lot / Code Info
Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android
Root Cause
Software design
Action Taken
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.