Events

Rappel de ACCUCHEK Connect Diabetes Management App

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Roche Diabetes Care, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    75241
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0586-2017
  • Date de mise en oeuvre de l'événement
    2016-09-14
  • Date de publication de l'événement
    2016-11-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149743
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Calculator, drug dose - Product Code NDC
  • Cause
    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
    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,

Device

ACCUCHEK Connect Diabetes Management App
  • Modèle / numéro de série
    Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016; Catalog number 07562462001 / GTIN number 00365702700000
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • 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
  • Description du dispositif
    Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016
  • Manufacturer
    Roche Diabetes Care, Inc.

Manufacturer

Roche Diabetes Care, Inc.
  • Adresse du fabricant
    Roche Diabetes Care, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Société-mère du fabricant (2017)
    Roche Holding AG
  • Source
    USFDA