Events

Safety Alert Or Field Safety Notices for GlucoMen LX Sensor blood glucose test strips 50 count used with the GlucoMen LX and GlucoMen LX PLUS meter

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Menarini.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2013/064
  • Event Number
    CON303150
  • Date
    2013-08-14
  • Event Date Posted
    2013-08-14
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON303150?tabName=allTabs
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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...
  • Model / Serial
  • Product Description
    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