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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 September 14, 2016
Date Posted November 16, 2016
Recall Status1 Terminated 3 on June 06, 2017
Recall Number Z-0586-2017
Recall Event ID 75241
510(K)Number K150910  
Product Classification Calculator, drug dose - Product Code NDC
Product Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
Code Information Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016; Catalog number 07562462001 / GTIN number 00365702700000
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
Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS), released on July 11, 2016, due to the software containing a programming error (bug) in the Bolus Advisor feature, which could lead to an incorrect insulin bolus recommendation.
FDA Determined
Cause 2
Software design (manufacturing process)
Action Roche Diabetes Care, Inc., initiated a voluntary recall on September 14, 2016, of the version 1.2.0 of the Accu-Chek Connect app on iOS products (iPhone, iPad). The Prescription Activation Service (PAS) which allows the users to activate the bolus advice feature was placed on product hold immediately. This measure prevented any new bolus advice activations. An updated version (V 1.2.2) of the Accu-Chek Connect Diabetes Management App for iOS that contains the fix for the issue was released on August 29, 2016. Patients were instructed to: ¿ If you use the Accu-Chek Connect App on an IOS product (iPhone, iPad), please verify that you have installed the newest version of the app. ¿ Contact Accu-Chek Customer Care at 1-800-628-3346 if you have additional questions. HCPs were instructed to provide a copy of the UMDC to those patients to whom they have prescribed the Bolus Advisor on the Accu-Chek Connect App. No product returns are expected. Customers with questions may contact Accu-Chek Customer Care at 1-800-628-3346. For further questions please call (317) 521-4312,
Quantity in Commerce 7,909 downloads of iOS version 1.2.0 of the Accu-Chek Connect Diabetes Management App in the US and 8,775 downloads Internationally
Distribution US Distribution to the states of : Alabama, Arizona, Arkansas, California, Colorado, Connecticut, DC, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin Foreign: None provided
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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