Events

Alerte De Sécurité sur Animas Insulin Pump

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

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
    2012-07-25
  • Date de publication de l'événement
    2012-07-25
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120725a.html
  • 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
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: animas insulin pump the medicines and healthcare products regulatory agency (mhra), united kingdom issued a medical device safety alert concerning animas insulin pump manufactured by animas corporation. according to animas, some patients experienced gradual wear of their insulin pump keypad that led to damage, such as tearing or peeling of the edge of the keypad from the pump. therefore, animas has improved the durability of the insulin pump keypad, which includes the ok button, up arrow/ down arrow buttons, and the contrast button. the manufacturer advised all animas insulin pump users to examine their insulin pump keypad for wear or damage on a regular basis, as part of the routine process of pump inspection. animas provides a warranty for a period of four years from the date of purchase in most cases. if a customer has a confirmed issue related to the keypad and he/she is covered by the animas warranty, animas will replace the pump at no charge. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 july 2012.

Device

Animas Insulin Pump
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Animas Insulin Pump
  • Manufacturer
    Animas Corporation

Manufacturer

Animas Corporation