Events

Retiro De Equipo (Recall) de ACCUCHEK

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 Diagnostics Operations, 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
    66605
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0385-2014
  • Fecha de inicio del evento
    2013-10-25
  • Fecha de publicación del evento
    2013-11-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-01-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122710
  • 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
    System, test, blood glucose, over the counter - Product Code NBW
  • Causa
    There is a software synchronization issue with the accu-chek combo system. in rare cases, when the manual pump option is chosen on the accu-chek aviva combo meter, there is a possibility of receiving an incorrect bolus advice recommendation that may cause a temporary under delivery of insulin.
  • Acción
    The firm, Roche Diagnostics, sent an "URGENT MEDICAL DEVICE CORRECTION (UMDC)" letter dated October 29, 2013, via UPS to their consignees/customers. The letter described the product, problem and actions to be taken. The UMDC informed them of the software synchronization issue with the ACCU-CHEK Combo system that may cause a temporary under delivery of insulin. The customers were instructed to ensure they properly deliver the correction bolus when utilizing the Manual Pump option, as instructed in the Owners Booklet; and complete and return the Business Reply Card via fax to 1-877-282-0223. The Distributors were instructed to provide the UMDC to their direct customers. The HCPs were instructed to remind their patients to follow the instructions in the Accu-Chek Aviva Combo Meter Advanced Owners Booklet when utilizing Manual Pump option. Questions about the information contained in this UMDC are directed to ACCU-CHEK Pump Support, 24 hours a day, seven days a week at 1-800-688-4578.

Device

ACCUCHEK
  • Modelo / Serial
    AccuChek Aviva Combo meter 05075645005 packaged in Accu-Chek Combo Kit mg US/English version, 05458544001 and Accu-Chek Combo Kit mg US/Spanish version, 05504686001.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ || The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • Dirección del fabricante
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Empresa matriz del fabricante (2017)
    Roche Holding AG
  • Source
    USFDA