Events

Alerte De Sécurité sur accu-chek spirit combo insulin pumps

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
    2014-10-03
  • Date de publication de l'événement
    2014-10-03
  • 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_20141003a.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 pumps the australia therapeutic goods administration (tga) posted a medical device safety alert concerning accu-chek spirit combo insulin pumps manufactured by roche diagnostics. the manufacturer has become aware that in a limited number of cases, patients using the accu-chek spirit combo insulin pump may experience a loss of the date and time settings. investigation of the situation revealed that this issue may occur if the pump capacitor fails to function properly due to a leakage. the capacitor provides the necessary voltage to save time and date settings during power interruption, typically during a battery change. the manufacturer is advising end users and healthcare professionals of the potential issue. end users are advised to ensure that the time and date are set correctly after a battery change. users who experience any failures are requested contact the manufacturer to arrange for a replacement pump. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to the following link:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-01063-1 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 03 october 2014.

Device

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

Manufacturer

Roche Diagnostics