Alerte De Sécurité sur blood glucose monitoring systems

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Abbott Diabetes Care.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Press release
  • Cause
    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.



  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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