Events

Avis De Sécurité sur GlucoMen LX Sensor blood glucose test strips 50 count (product code 38877), used with the GlucoMen LX and GlucoMen LX PLUS meter

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par A. Menarini Diagnostics S.r.l..

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
    Field Safety Notice
  • Numéro de l'événement
    SN2013(09)
  • Date
    2013-08-20
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    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 / Alertes
    "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."
  • Notes supplémentaires dans les données
  • Cause
    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...
  • Modèle / numéro de série
  • Description du dispositif
    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.