Events

Alerte De Sécurité sur GlucoMen LX Sensor blood glucose test strips 50 count

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

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
    2013-08-15
  • Date de publication de l'événement
    2013-08-15
  • 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_20130815.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: a. menarini diagnostics glucomen lx sensor blood glucose test strips 50 count the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) issued a medical device alert and a press release concerning glucomen lx sensor blood glucose test strips 50 count (product code 38877). they are used with the glucomen lx and glucomen lx plus meter and they are manufactured by menarini in italy. the affected lot numbers are 3212214249 (expiry date 31 aug 2014) and 3212219249 (expiry date 31 aug 2014). according to the mhra, the affected lots have been contaminated during manufacture, and may give an overestimation of blood glucose levels, potentially resulting in inappropriate insulin administration. there is currently no evidence that uk patients have been affected. the mhra provides the following advice to the affected users/ healthcare personnel: identify and quarantine affected lots. identify patients using these meters and advise them that they should return and not use strips from the affected lots. ensure that users who return strips from the affected lots can continue to monitor their blood glucose. contact menarini to arrange the return of any strips from the affected lots. according to the local supplier, the affected products were not distributed in hong kong. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/newscentre/pressreleases/con305472 http://www.Mhra.Gov.Uk/publications/safetywarnings/medicaldevicealerts/con303150 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 august 2013.

Device

GlucoMen LX Sensor blood glucose test strips 50 count
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: A. Menarini Diagnostics GlucoMen LX Sensor blood glucose test strips 50 count
  • Manufacturer
    Menarini in Italy

Manufacturer

Menarini in Italy