Events

Alerte De Sécurité sur Accu-Chek Insight insulin pump cartridge (self-filled)

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
    2015-03-03
  • Date de publication de l'événement
    2015-03-03
  • 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_20150303.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: accu-chek insight insulin pump cartridge (self-filled) the medicines and healthcare products regulatory agency (mhra) posted a medical device safety alert concerning accu-chek insight insulin pump cartridge (self-filled) manufactured by roche diagnostics. [lot numbers: 1083036, 1083193, 1083533, 1083534, 1083535, 1083536, 1083537, 1089205, 1089206, 1090593, 1090763, 1091203, 1091204, d04032014, d14112013] the manufacturer has become aware of a potential insulin leakage occurring with some manufacturing lots of the accu-chek insight insulin pump cartridge (self-filled) used with the accu-chek insight insulin pump system. the potential risk is smaller than expected doses of insulin may be delivered if insulin leakage occurs. patient may experience too high blood glucose levels, which if left untreated, can result in a diabetic ketoacidosis. death could result. the manufacturer is advising end users not to use and discard any cartridges of the above listed lots. according to the local supplier, the affected products are not distributed in hong kong. for details, please refer to the following link: http://mhra.Filecamp.Com/public/file/28bg-c089h6uh if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 03 march 2015.

Device

Accu-Chek Insight insulin pump cartridge (self-filled)
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Accu-Chek Insight insulin pump cartridge (self-filled)
  • Manufacturer
    Roche Diagnostics

Manufacturer

Roche Diagnostics