Events

Alerte De Sécurité sur Accu-Chek Mobile System

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.

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
    2014-05-23
  • Date de publication de l'événement
    2014-05-23
  • 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_20140523.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 accu-chek mobile system medical device manufacturer, roche, has issued a field safety notice concerning accu-chek mobile system. the manufacturer is introducing enhanced instructions and training for the use of the accu-chek mobile system. the new and enhanced training materials will be included in the accu-chek mobile kits and will be distributed to current accu-chek mobile users. according to the manufacturer, the strip-free accu-chek mobile blood glucose monitoring system offers a unique testing procedure, which requires particular awareness of people with diabetes regarding its proper handling. the manufacturer has identified that a small number of people with diabetes using the affected device have experienced falsely elevated blood glucose readings when using the system as a result of not following the described and labelled handling instructions. such improper handling can include, for example, unclean hands contaminated with glucose-containing substances, pressing the finger too hard and too long on the test field or smearing the blood while performing a test. the manufacturer has decided to enhance its training and handling instructions for the accu-chek mobile system to increase their visibility in the meter kit to ensure people with diabetes’ understanding of how to appropriately use the system. this will enable the users to obtain safe and reliable blood glucose (bg) readings at all times. the manufacturer advises patients that they can continue to use their accu-chek mobile device safely and reliably by carefully following the instructions included in the new training leaflet. if patients have concerns about the accuracy of a bg reading, they should refer to the possible sources of error listed in the user manual and perform a test with a control solution or they should contact their healthcare provider and follow the individual advice. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 may 2014.

Device

Accu-Chek Mobile System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Roche Accu-Chek Mobile System
  • Manufacturer
    Roche

Manufacturer

Roche