Events

Alerte De Sécurité sur Viterion V100 and V500 Telehealth Monitors

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

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
    2012-12-11
  • Date de publication de l'événement
    2012-12-11
  • 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_20121211.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: viterion v100 and v500 telehealth monitors the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning viterion v100 and v500 telehealth monitors manufactured by viterion telehealthcare. according to viterion, the affected models v100 and v500 do not accept out-of-measuring-range results, i.E. results marked “hi” or “lo” from certain blood glucose meters. the affected meters are bayer’s contour and roche’s accu-chek advantage 03 and 04 meters. this out-of-measuring-range data is not being sent from the patients’ telehealth monitors to the clinician application software (eunet), and hence the healthcare professionals are not able to review the out-of-measuring-range patient blood glucose data. moreover, for those patients with diabetes who are instructed by their healthcare professional to enter blood sugar results manually on these monitors, only results between 1.1 and 33.3 mmol/l may be entered. results outside of the meter’s measurable range cannot be manually entered on these viterion monitors. viterion advises the affected patients, who see hi or lo displayed on the blood glucose meter, to contact their healthcare professional immediately. besides, healthcare professionals should watch out for any ‘skipped’ or ‘timeout’ values seen in patient reports. according to the local supplier, the affected products have not been distributed in hong kong. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con213146 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 11 december 2012.

Device

Viterion V100 and V500 Telehealth Monitors
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Viterion V100 and V500 Telehealth Monitors
  • Manufacturer
    Viterion TeleHealthcare

Manufacturer

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