Events

Field Safety Notices about GlucoMen LX Sensor blood glucose test strips 50 count (product code 38877), used with the GlucoMen LX and GlucoMen LX PLUS meter

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland that was produced by A. Menarini Diagnostics S.r.l..

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
    Field Safety Notice
  • Event Number
    SN2013(09)
  • Date
    2013-08-20
  • Event Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/glucomen-lx-sensor-blood-glucose-test-strips-50-count-(product-code-38877)-used-with-the-glucomen-lx-and-glucomen-lx-plus-meter&id=a996f825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alerts
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Extra notes in the data
  • Reason
    The irish medicines board (imb) has been notified that certain lots of glucomen lx sensor blood glucose test strips have been subject to a manufacturing fault and may give erroneously high blood glucose results, potentially leading to inappropriate insulin administration.
  • Action
    Advice for End Users / Patients:  1. Identify, discontinue use and quarantine devices from the affected lot.  2. Return any devices from the affected lot to your pharmacy or distributor. Alternatively, contact A. Menarini Diagnostics (UK) or Medicon Ireland to arrange for return of any devices from the affected lot.  3. Ensure that you can continue to appropriately monitor your blood glucose via test strips from a different lot number or by other means. This should be done in consultation with your healthcare professional.  Advice for Healthcare Professionals / Pharmacists / Distributors:  1. Identify, discontinue distribution and quarantine devices from the affected lot.  2. Return any devices from the affected lot to your distributor. Alternatively, contact A. Menarini Diagnostics (UK) or Medicon Ireland to arrange for return of any devices from the affected lot.  3. Please also pass this notice on to any end user or organisation where the potentially affected devices have been transferred or who are using the GlucoMen LX and GlucoMen LX PLUS meters.  4. Ensure that the appropriate personnel and end users are made aware of this notice.  5. Ensure that end users who return blood glucose test strips from the affected lots can continue to appropriately monitor their blood glucose.

Device

GlucoMen LX Sensor blood glucose test strips 50 count (product code 38877), used with the GlucoMe...
  • Model / Serial
  • Product Description
    GlucoMen LX Sensor blood glucose test strips 50 count (product code 38877), used with the GlucoMen LX and GlucoMen LX PLUS meter
  • Manufacturer
    A. Menarini Diagnostics S.r.l.

Manufacturer

A. Menarini Diagnostics S.r.l.