Events

Alerte Ou Avis De Sécurité sur GlucoMen LX Sensor blood glucose test strips 50 count used with the GlucoMen LX and GlucoMen LX PLUS meter

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Menarini.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2013/064
  • Numéro de l'événement
    CON303150
  • Date
    2013-08-14
  • Date de publication de l'événement
    2013-08-14
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON303150?tabName=allTabs
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Notes supplémentaires dans les données
  • Cause
    Affected lots have been contaminated during manufacture, and may give an overestimation of blood glucose levels, potentially resulting in inappropriate insulin administration. the manufacturer distributed the affected lots in the uk via wholesale outlets during october and november 2012. the product may, however, still remain with users or pharmacies. there is currently no evidence that uk patients have been affected.
  • Action
    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.

Device

GlucoMen LX Sensor blood glucose test strips 50 count used with the GlucoMen LX and GlucoMen LX P...
  • Modèle / numéro de série
  • Description du dispositif
    Home use blood glucose test strips GlucoMen LX Sensor blood glucose test strips 50 count (product code 38877), used with the GlucoMen LX and GlucoMen LX PLUS meter manufactured by Menarini. Lot 3212214249, expiry date 31-08-2014 and lot 3212219249, expiry date 31-08-2014. Illustration of tub, containing 50 test strips.
  • Manufacturer
    Menarini

Manufacturer

Menarini