Events

Alerta De Seguridad para Optium Xceed

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

¿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
    2007-09-11
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/press_20070911.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
    Medical device alert for blood glucose meters the department of health (dh) was notified by the food and drug administration of the united states today (september 11) about a worldwide medical device alert on a type of blood glucose meters, the display screen of which may not work properly when dropped onto a hard surface. a dh spokesman said the alert was initiated by the manufacturer, abbott diabetes care, involving blood glucose meters manufactured after january 2007. the display screen of the affected meters, marked as "abbott optium xceed", may not work properly or may appear blank if dropped on a hard surface, thus making the users unable to view the blood glucose test results. it was revealed that a total of 857 affected devices were sold in hong kong but none of them were released to hospitals. as a precautionary measure, users should not use the blood glucose monitor if the display shows missing or blank section. they should contact the local agent or supplier for replacement. "users should ensure a full display show each time the blood glucose monitor is turned on, especially before using the monitor to check the blood glucose level," the spokesman said. the spokesman said dh had alerted the hospital authority, private hospitals, nursing homes and medical professional associations to this medical device correction. dh has not received any report of adverse events arising from this issue. the spokesman said members of the public using the meters concerned should contact the local agent by calling its hotline 2806 4488 during office hours for advice. relevant information is available at the manufacturer's website. ends/tuesday, september 11, 2007 nnnn.

Device

Optium Xceed
  • Modelo / Serial
  • Descripción del producto
    Press release: Medical Device Alert for Blood Glucose Meters
  • Manufacturer
    Abbott

Manufacturer

Abbott
  • 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