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:
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