Events

Retiro De Equipo (Recall) de Device Recall AccuChek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android

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
    76870
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1899-2017
  • Fecha de inicio del evento
    2017-03-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-01-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154435
  • 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
    A program error (bug) in the bolus advisor feature, which could result in incorrect bolus advice and a potential insulin over-delivery.
  • Acción
    Roche Diabetes Care, Inc. discovered a software issue in the Accu-Chek Connect app versions 2.0.0, 2.0.1, and 2.1.0 that can result in incorrect bolus recommendations. This software bug may result in errors in the active insulin calculation, creating the potential for a false high insulin bolus recommendation. An insulin bolus delivered based on potentially incorrect bolus advice could lead to serious health consequences such as hypoglycemia. Customer notices were distributed via mail on 03/30/2017, and the firm's website was also updated with recall information on that day. Customers were instructed to do the following: discontinue use of the bolus advisor feature in app versions 2.0.0, 2.0.1, and 2.1.0 (iOS & Android) until the corrected version is available. ¿ Provide patients with a copy of the enclosed Urgent Medical Device Correction 17-001. ¿ Complete the enclosed faxback form and fax it to Roche Diabetes Care, Inc., at 1-888-912-8456. ¿ If you have questions about the information in this notification, please contact Accu-Chek Customer Care by visiting accu-chek.com or by calling 1-800-688-4578. The corrected version of the app is expected to be available on or about April 13, 2017. New patients will be able to begin using the bolus advisor feature once the corrected version is available. Please advise your patients to visit accu-chek.com for updates regarding the availability of the corrected version of the app.

Device

Device Recall AccuChek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS a...
  • Modelo / Serial
    Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, DE, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV
  • Descripción del producto
    Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android || Product Usage: || This is a digital product available for download direct to customers from the Apple App Store and the Google Play Store. The total number of downloads is not available. The number of unique users for each affected version from the date of initial distribution through 03/23/2017 is noted in 7a. However, some users will have used all three affected versions as they upgraded from version to version when the versions became available and many others will have tried the app and discontinued use. In the last 30 days, 02/22/2017 03/23/2017, there have been 16,781 unique users in the US with 264 of those seeking bolus advice and 19,268 unique users in the rest of world (excluding Canada) with 415 of those users seeking bolus advice.
  • 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