Events

Field Safety Notices about Glucofacts Deluxe

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 an issue we have identified with the latest version of glucofacts deluxe (3.10.07) when it is receiving insulin and carbohydrate values from the contour®next/plus one meter that were manually entered into the contour® diabetes app. please note that this issue only affects users of glucofacts deluxe version 3.10.07 who are using it with the contour®next/plus one meter and have entered insulin and carbohydrate values in the contour® diabetes app. if you are using a contour®next/plus one meter without the app or using any other contour® meter, you are not affected and can use glucofacts deluxe without any limitations. blood glucose measurements transferred from all contour® meters, including contour®next/plus one, are also unaffected. .

Device

Glucofacts Deluxe

Manufacturer

Ascensia Diabetes Care