Events

Alerta De Seguridad para FreeStyle Lite blood glucose test strips

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
    2013-11-26
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131126a.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
    Further recall of selected lots of freestyle lite blood glucose test strips the department of health (dh) today (november 26) drew public attention to abbott diabetes care's further recall of other selected lots of its freestyle lite blood glucose test strips due to the potential for giving erroneously low blood glucose results when used in conjunction with certain brands of blood glucose meters also manufactured by the company. further to the press release issued by the dh yesterday (november 25) on the recall of certain lots of freestyle and freestyle lite blood glucose test strips by abbott diabetes care, the department, through its routine surveillance on medical devices, noticed abbott diabetes care's recall notice posted by the united kingdom's medicines and healthcare products regulatory agency involving three other lots of freestyle lite blood glucose test strips (lot numbers: 1284962, 1366626 and 1372611). according to the notice, the three affected lots may produce erroneously low blood glucose results and out of range control solution results when used in conjunction with freestyle blood glucose meters, freestyle mini blood glucose meters, freestyle navigator and the freestyle meter built into the omnipodsystem. 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 hyperglycaemia. "preliminary enquiries with the local supplier, abbott laboratories limited, revealed no evidence of the affected products having been distributed in hong kong. the dh will continue to monitor the situation," the spokesman said. so far, the dh has not received any local reports of adverse events arising from use of the affected products. people who have the test strips belonging to the affected lots and are using the specific brands of glucose meters concerned should contact abbott laboratories limited for advice and follow-up," the spokesman stressed. the company has set up a customer service hotline, 5808 4196, to answer related enquiries. ends.

Device

FreeStyle Lite blood glucose test strips
  • Modelo / Serial
  • Descripción del producto
    Press release: Further recall of selected lots of FreeStyle Lite blood glucose test strips
  • 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