My HPRA: Register

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

Notice type: Recall

Date: 20/08/2013

  

Product name or type:
GlucoMen LX Sensor blood glucose test strips 50 count (product code 38877), used with the GlucoMen LX and GlucoMen LX PLUS meter

Reference:
SN2013(09)

Manufacturer Or Supplier:
A. Menarini Diagnostics S.r.l. (Italy)

Target Audience:
All Hospital staff 
All Nursing Home staff 
Risk Managers 
Nursing Managers 
Hospital Pharmacists 
Diabetic Clinics/ outpatients 
Diabetic nurse specialists 
Diabetic departments 
Endocrinology units 
Endocrinology Consultants 
Paediatric wards 
Laboratory Managers 
Chief Medical Scientists 
Purchasing / Procurement / Material Managers 
Pharmacists supplying these devices 
General Practitioners 
Healthcare professionals who use these devices 
Healthcare professionals managing patients who use these devices 
Carers 
General public

Problem Or Issue:
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.

Background Information Or Related Documents:
A. Menarini Diagnostics (UK) and the distributor Medicon Ireland have advised that blood glucose test strips from affected lot number 3212214249 (expiry date 2014-08-31) were supplied to the Irish market. Based on stock distribution patterns, both A. Menarini Diagnostics (UK) and Medicon Ireland believe that is unlikely that strips from this lot remain in circulation. Furthermore, A. Menarini Diagnostics has indicated that only a limited number of strips from the lot are affected by this issue. 

A. Menarini Diagnostics (UK) and Medicon Ireland have confirmed that the above lot number is the only affected lot which they supplied to the Irish market; other affected lots (3212145249, 3212278249, 3212219249 and 3212251249) have been distributed in other European countries

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

Actions To Be Taken:
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. 

Further Information:
ENQUIRIES: 

All adverse incidents relating to a medical device should be reported to the: 

Health Products Regulatory Authority 
Kevin O’Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2 

Telephone: +353-1-6764971 
Fax: +353-1-6344033 
E-mail: devicesafety@hpra.ie
Website: www.hpra.ie 

Enquiries to the distributor should be addressed to: 

Mr. Jim McGrory 
Medicon Ireland Ltd. 
1a/1b Meridian Estate 
Carnbane Business Park 
Newry 
Co. Down 
BT356QH 
Northern Ireland 

Telephone: +44 2830 835 500 
Fax: + 44 2830 835 544 
E-mail: jimmcg@mediconire.com 

Enquiries to the manufacturer should be addressed (via their UK affiliate) to: 

Mr. Tony Jones 
A. Menarini Diagnostics Ltd. (UK) 
405 Wharfedale Road 
Winnersh-Wokingham 
RG41 5RA 
Berkshire 
United Kingdom 

Telephone: +44 1189 444 100 or (+44 800 243 667) 
Fax: +44 1189 444 123 
E-mail: tony.jones@menarinidiag.co.uk 

Please click here to view a PDF version of this Safety Notice 

« Back