Events

Alerte De Sécurité sur accu-chek spirit combo 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 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
    2014-03-12
  • Date de publication de l'événement
    2014-03-12
  • 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_20140312.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: roche diagnostics accu-chek spirit combo insulin pump the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device alert concerning accu-chek spirit combo insulin pump, manufactured by roche diagnostics. the affected serial numbers are from 10171897 to 10281629 (inclusive). there is an increased risk that the vibration alarm will not work, as a result of a changed component. this fault will only be detected at pump start up, when it will display an ‘e-7’ error message and give an audible signal, but will fail to start. there is a risk of treatment delay. the manufacturer advises users that: if a delay to insulin therapy could compromise patient safety, they should consider using an alternative device. when using these pumps, they should have a syringe or insulin pen available in case the pump stops. if the pump displays an ‘e-7’ error, they should contact local supplier for a replacement. for details, please refer to mhra websitehttp://www.Mhra.Gov.Uk/publications/safetywarnings/medicaldevicealerts/con392813 if you are in possession of the product, please contact your supplier for necessary actions. posted on 12 mar 2014.

Device

accu-chek spirit combo insulin pump
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Roche Diagnostics Accu-Chek Spirit Combo insulin pump
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics