Events

Retiro De Equipo (Recall) de Freestyle Navigator Continuous Glucose Monitor 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 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
    52635
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1445-2010
  • Fecha de inicio del evento
    2009-04-14
  • Fecha de publicación del evento
    2010-04-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-03-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89943
  • 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
    Continuous glucose monitor - Product Code MDS
  • Causa
    Potential failure or inaccurate readings--the device's plastic housing near the battery compartment may crack, and allow moisture to enter.
  • Acción
    Notification letters were issued to FreeStyle Navigator customers via certified mail and notification was posted on the Abbott Diabetes Care's Website. Customers were notified of the potential issue and actions to take: 1) if moisture is observed in the FreeStyle Navigator transmitter now or at any time, discontinue use of the transmitter and call Abbott Diabetes Care Customer Care at 1-800-418-6427 and 2) if a loss of connection is encountered or if your results are not reliable or are inconsistent with how you feel, consult your User's Guide for troubleshooting guidelines. If the issue is not resolved, call Abbott Diabetes Care Customer Care at 1-800-418-6421. For outside-of-US accounts, the firm's regional offices will distribute notices to identified customers in the appropriate language.

Device

Freestyle Navigator Continuous Glucose Monitor System
  • Modelo / Serial
    Abbott Item # 70791-01; with multiple lot numbers, kits serial numbers, and Tx serial numbers. Lot numbers are these: 01M1928, 01M1978, 01M2038, 01M2178, 01M2528, and 01M3258. Kit Serial numbers beginning with: AAAH 090 or AAAH 139 or AAAH 158 or AAAH 187 or AAAH 195 or AAAH 268 or AAAH283 and followed by a five (5 )digit number. Tx Serial numbers beginning with: AAAH 090 or AAAH 139 or AAAH 158 or AAAH 187 or AAAH 195 or AAAH 268 or AAAH 283 and followed by a five (5) digit number.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States (OH, FL, NJ, CA, MS, MN, MA, and NY), France, Australia, the Netherlands, Sweden, the UK, Israel, Ireland and Germany.
  • Descripción del producto
    Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, ABB Warranty Kit Xmitter Nav, Abbott Item Number 70791-01, distributed by Abbott Diabetes Care Inc, Alameda, CA. || Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.
  • Manufacturer
    Abbott Diabetes Care, Inc.

Manufacturer

Abbott Diabetes Care, Inc.
  • Dirección del fabricante
    Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda CA 94502-7000
  • Source
    USFDA