Events

Alerta De Seguridad para blood glucose monitoring systems

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
    2014-03-03
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140303.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
    Press release
  • Causa
    Recall of certain brands of abbott diabetes care blood glucose monitoring systems the department of health (dh) today (february 28) drew public attention to the recall by abbott diabetes care of certain brands of its blood glucose monitoring systems which may produce inaccurate glucose results. the dh received the above safety alert from the local supplier, abbott laboratories limited. the manufacturer, abbott diabetes care, has identified through internal testing and investigation that certain brands of their blood glucose monitoring systems, namely freestyle, freestyle flash, freestyle papillon, freestyle mini, freestyle papillon mini, optium mini blood glucose meters, freestyle navigator continuous glucose monitoring system and freestyle blood glucose meter built into the omnipod insulin management system, have the potential to produce erroneously low blood glucose results when used in conjunction with any freestyle test strip. a spokesman for the dh explained that falsely low blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hyperglycemia. so far, the dh has not received any local report of adverse events arising from use of the affected products. people who are using the specific brands of glucose meters concerned should contact abbott laboratories limited for advice and follow-up," the spokesman added. the company has set up a customer service hotline 5808 4196 to answer related enquiries. ends/friday, february 28, 2014.

Device

blood glucose monitoring systems

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