Events

Retiro De Equipo (Recall) de Device Recall Easy Glucose Monitoring 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 Abbott Laboratories Medisense Products.

¿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
    33301
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0052-06
  • Fecha de inicio del evento
    2005-06-07
  • Fecha de publicación del evento
    2005-10-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-05-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41648
  • 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
    User may inadvertently change the units of measure from mg/dl to mmol/l and the blood glucose results could be misinterpreted. this may lead to under treatment and potential for hyperglycemia.
  • Acción
    The firm has undertaken a field correction to notify their customers of the potential for the units of measure to be changed. The firm plans to (1) include a flyer in all Precision Xtra and FreeStyle meter kits to reinforce current labeling regarding units of measure and update the Frequently Asked Questions section of the website to reinforce the units of measure change, (2) Lock out the units of measure in new production meters to eliminate potential to change the units of measure settings, update the meter kits with a flyer to override the section of the manual indicating that the units of measure are changeable, and change the product insert in glucose test strips to indicate which units of measure are appropriate for the user and (3) update the labeling to indicate that the units of measure are not user configurable to eliminate the need for the flier.

Device

Device Recall Easy Glucose Monitoring System
  • Modelo / Serial
    All lot numbers are included in this recall.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Approximately 10,005,206 meters have been distributed worldwide since 1999, with 5,885,332 meters distributed in the US, and 4,517,211 in use.
  • Descripción del producto
    Easy Glucose Monitoring System; || Recalling Firm/Manufacturer ¿ || Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502
  • Manufacturer
    Abbott Laboratories Medisense Products

Manufacturer

Abbott Laboratories Medisense Products
  • Dirección del fabricante
    Abbott Laboratories Medisense Products, 1360 S Loop Rd, Alameda CA 94502-7000
  • Source
    USFDA