Events

Safety Alert for GLUCOFACTS DELUXE software version 3.01

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Bayer Healthcare.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-09-11
  • Event Date Posted
    2012-09-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120911.html
  • Notes / Alerts
    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.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: bayer glucofacts deluxe software version 3.01 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning glucofacts deluxe software version 3.01 manufactured by bayer healthcare. according to bayer, with english as the language setting within glucofacts deluxe software, the default time format used for display is a 12 hour time format (am/pm). the issues with glucofacts deluxe software version 3.01 include the following: "am" and "pm" designations do not appear in association with the time stamp in the logbook view, pm times are listed with a "0" in front of them for times earlier than 10:00 pm. for example, 5:00 pm is reported as 05:00. bayer explained that the results viewed on the meter are not affected by the time stamp issue. this issue only occurs when results are viewed on a computer. to interpret the results and the associated time stamps appropriately in the logbook view of glucofacts deluxe, bayer advised the users to review the column headings for the appropriate time of day. in addition, bayer will provide a software update which will be available online to correct the issue. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/ safetywarningsalertsandrecalls/fieldsafetynotices/con184398 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 11 september 2012.

Device

GLUCOFACTS DELUXE software version 3.01
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Bayer GLUCOFACTS DELUXE software version 3.01
  • Manufacturer
    Bayer Healthcare

Manufacturer

Bayer Healthcare
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    DH