Events

Retiro De Equipo (Recall) de ACCUCHEK Connect Diabetes Management App

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Roche Diabetes Care, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    75241
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0586-2017
  • Fecha de inicio del evento
    2016-09-14
  • Fecha de publicación del evento
    2016-11-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-06-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149743
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Calculator, drug dose - Product Code NDC
  • Causa
    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.
  • Acción
    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
  • Modelo / Serial
    Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016; Catalog number 07562462001 / GTIN number 00365702700000
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    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
  • Descripción del producto
    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.
  • Dirección del fabricante
    Roche Diabetes Care, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Empresa matriz del fabricante (2017)
    Roche Holding AG
  • Source
    USFDA