Alerte De Sécurité sur accu-chek flexlink plus infusion sets

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

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
    Safety alert on accu-chek flexlink plus infusion sets the department of health (dh) today (march 2) warned the public not to use accu-chek flexlink plus infusion sets, manufactured by roche diagnostics (roche), because of the potential for under delivery of insulin due to a kinked cannula when inserting the infusion set. the dh, through its routine surveillance of medical devices, noticed that roche has announced a recall of the above product. roche's investigation into complaints regarding kinked cannulas revealed that in some cases the distance between the needle cut and the end of the soft cannula is too small and may contribute to an impaired cannula. the malfunction of infusion sets may result in under delivery of insulin leading to elevation of blood glucose levels, or hyperglycemia. symptoms of hyperglycemia include nausea/vomiting, blurred vision, excessive thirst or hunger, frequent urination, fatigue and headache. a dh spokesman remarked that hyperglycemia is a significant health risk, as untreated hyperglycemia may lead to death in serious cases. although preliminary investigation has revealed that there is neither record of marketing of the product nor report of such adverse events in hong kong, the potentially serious consequences and the fact that there may be occasional patients here who have somehow obtained the devices overseas justify a public alert. roche diagnostics (hong kong) ltd has set up a hotline, 2485 7512, to answer public enquiries from 9am to 12 noon, and from 2pm to 5pm between monday and friday. meanwhile, dh has informed all public and private hospitals and medical professional associations about the matter and advised them to remain vigilant. the spokesman said: "dh will closely monitor developments. members of the public should consult their healthcare professionals for advice if in doubt or feel unwell." ends/wednesday, march 2, 2011 issued at hkt 16:35.