Events

Alerte De Sécurité sur GLUCOFACTS DELUXE software version 3.01

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Bayer Healthcare.

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
    2012-09-11
  • Date de publication de l'événement
    2012-09-11
  • 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_20120911.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: 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
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Bayer GLUCOFACTS DELUXE software version 3.01
  • Manufacturer
    Bayer Healthcare

Manufacturer

Bayer Healthcare
  • Société-mère du fabricant (2017)
    Bayer AG
  • Source
    DH