Events

Retiro De Equipo (Recall) de Meter Remote for OneTouch Ping Glucose Management System

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 Animas Corporation.

¿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
    50796
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0955-2009
  • Fecha de inicio del evento
    2008-10-27
  • Fecha de publicación del evento
    2009-03-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-12-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77315
  • 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
    Insulin Infusion Pump - Product Code LZG
  • Causa
    Incorrect dosing recommendation.
  • Acción
    The recalling firm issued Urgent: Medical Device Correction letters dated 10/27/08 to their customers/user to inform them of the problem. The letter stated that the firm was in the process of correcting the issue and that a new OneTouch Ping Meter-Remote would be provided as soon as one became available. In the interim, customers could still safely use their OneTouch Ping System provided that they use the ezCarb calculator on the meter-remote when it is paired and communicating with the pump. The letter listed guidelines to ensure that the device is properly communicating with the pump. The letter stated that customers should follow the directions in the Owner's Booklet to troubleshoot any communication issues. Questions regarding this letter were to be directed to Animas at 866-423-4087. A patient acknowledgment letter dated November 18, 2008 was also issued. Another Urgent: Medical Device Correction letter, dated November 2008, was issued along with the replacement device. This letter asked customers to download their current meter-remote data, set up their replacement meter-remote, and then return their current meter-remote.

Device

Meter Remote for OneTouch Ping Glucose Management System
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution --- including states of KY, UT, FL, OH, MA, and TX.
  • Descripción del producto
    Meter Remote for OneTouch Ping Glucose Management System
  • Manufacturer
    Animas Corporation

Manufacturer

Animas Corporation
  • Dirección del fabricante
    Animas Corporation, 200 Lawrence Dr, West Chester PA 19380
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA