GlucoMen LX Sensor blood glucose test strips 50 count (product code 38877), used with the GlucoMen LX and GlucoMen LX PLUS meter 에 대한 현장 안전성 서한

Field Safety Notice

SN2013(09)

2013-08-20

Ireland

HPRA

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

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.

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.