Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016

FDA device recall Z-0586-2017 · posted 2016-11-16 · Terminated

Recall details

Recalling firm

Roche Diabetes Care, Inc.

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.

Action taken

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,

Root cause

Software design (manufacturing process)

Status

Terminated

Product code

NDC

Quantity affected

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, Ma

Date initiated

2016-09-14

Date posted

2016-11-16

Date terminated

2017-06-06

Location

Indianapolis, IN

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