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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 December 20, 2016
Date Posted January 26, 2017
Recall Status1 Terminated 3 on September 05, 2017
Recall Number Z-1099-2017
Recall Event ID 76147
510(K)Number K150910  
Product Classification Calculator, drug dose - Product Code NDC
Product Accu-Chek Connect Diabetes Management App
Code Information Catalog number 07562462001 / GTIN number 00365702700000 Catalog number 07250452001 / GTIN number 00365702700017
Recalling Firm/
Manufacturer
Roche Diabetes Care, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
Manufacturer Reason
for Recall
iOS and Android: Under certain conditions the affected app versions may disregard historical bolus data potentially leading to an incorrect bolus insulin recommendation being provided to the user. iOS only: Pairing and using multiple meters with the Accu-Chek Connect app can under rare circumstances cause the bolus advisor to fail to offer a correction bolus recommendation within the eligible time window following a blood glucose measurement (10  15 minutes). Depending on the individual metabolic situation potentially incorrect bolus advice could lead to serious health consequences such as hypoglycemia. Both software issues may also cause the amount of active insulin displayed during the bolus calculation process to be incorrect and should not be used to manually calculate a bolus.
FDA Determined
Cause 2
Software design
Action Customers were notified via Google Play Store or the Apple App Store that an update to the Accu-Chek Connect App was available on December 20, 2016.. The description of the new version available in the app stores indicated that the new version resolved issues with the Bolus Advisor. It also includes direction to the Accu-Chek website. On December 21, 2016, information regarding the issues corrected with the new version was placed on the website. The information on the website was replaced on January 10, 2017, with the patient version of the Urgent Medical Device Correction (UMDC) which was sent on January 10, 2017, to US HCPs who have received prescription pads that would allow them to prescribe the bolus advice activation. If you have additional concerns, please contact the Accu-Chek Customer Service Center at 1- 800-858-8072. All other versions of the app as well as other Accu-Chek products using the bolus advice feature are not affected by this issue.
Quantity in Commerce 27243
Distribution Worldwide Distribution - Nationwide Distribution The Accu-Chek Connect App for iOS is distributed directly to end users via the Apple App Store. The Accu-Chek Connect App for Android is distributed directly to end users via the Google Play App Store.
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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