Alerta De Seguridad para FreeStyle InsuLinx Blood 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.

¿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
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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 insulinx blood glucose monitoring system the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning freestyle insulinx blood glucose monitoring system, manufactured by abbott. abbott has determined that at extremely high blood glucose levels of 56.8 mmol/l and above, the freestyle insulinx meter will display and store in memory an incorrect test result that is 56.8 mmol/l below the measured result. for example, a blood glucose value of 59.1 mmol/l will be displayed and stored as a value of 2.3 mmol/l (59.1 mmol/l–56.8 mmol/l = 2.3 mmol/l). if the freestyle insulinx meter displays an inaccurate low result, there may be a delay in identification and treatment of severe hyperglycemia, or incorrect treatment may be given. product recall and replacement is on-going from distributors and health care providers. the affected patients are advised to update the software on the affected meters immediately, or they can contact their local abbott diabetes care customer service for assistance. according to the local supplier, abbott diabetes care, the affected product has not been distributed in hong kong. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con261768 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 april 2013.



  • Empresa matriz del fabricante (2017)
  • 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.
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