Events

Field Safety Notices about CONTOUR® DIABETES App

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Ascensia Diabetes Care.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    We would like to inform you about a potential issue we have identified with the contour® diabetes app (version 1.2.0 or lower) when it is synchronizing data with the contour cloud. there is the potential for an isolated, very rare situation to occur where some of the data stored in the contour cloud may be incomplete. please note that this situation will only affect users using the same contour cloud account for the app on more than one mobile device (smartphone or tablet). the data on the contour® next/plus one meter and on the mobile device (“primary device”) that directly receives data from the meter are not affected, and will always show the correct and complete information including glucose values and meal markers. a health care professional report can still be generated and transmitted from the primary device (phone or tablet). if you have used the contour® diabetes app prior to version 1.2.0 in switzerland or poland this may be the second letter that you have received regarding this issue. version 1.2.0 did not completely resolve the issue. .

Device

CONTOUR® DIABETES App

Manufacturer

Ascensia Diabetes Care