Events

Alerta De Seguridad para FreeStyle Libre Flash Glucose Monitoring System

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Abbott Diabetes Care.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2014-10-14
  • Fecha de publicación del evento
    2014-10-14
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141014a.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: abbott diabetes care freestyle libre flash glucose monitoring system the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice (fsn) concerning freestyle libre flash glucose monitoring system, manufactured by abbott diabetes care. according to the fsn, one of the safety features of the freestyle libre system is the software, which is designed to disable the sensor if it identifies a possible loss of sensor power. in rare cases this disabling feature may not function correctly, and there is the potential for power loss to occur which may not be properly identified by the system. in these instances, when a scan is completed the sensor may provide previously collected glucose values as if they are current results. if this occurs, the results produced from the scan and seen on the reader screen may be erroneous. however, the built-in blood glucose meter system is unaffected by this issue. the above issue can be easily identified as the user would see the same glucose result on the screen each time they scanned during a period of power loss. they may also notice a gap in results on the 8-hour graph on the reader screen. if any reading from a scan seems unexpected or does not seem to match the way users are feeling, users should use the meter and test strips to perform a blood glucose test to verify the results produced by a scan. if the problem continues, users should contact abbott diabetes care customer service. furthermore, the manufacturer has made a change to the software that has corrected this issue for all newly manufactured freestyle libre sensors. for details, please refer to mhra website : http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con462307 according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 october 2014.

Device

FreeStyle Libre Flash Glucose Monitoring System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Abbott Diabetes Care FreeStyle Libre Flash Glucose Monitoring System
  • Manufacturer
    Abbott Diabetes Care

Manufacturer

Abbott Diabetes Care
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DH