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FreeStyle Mini® and FreeStyle® Blood Glucose Monitoring Systems

Notice type: Advisory

Date: 21/02/2014

  

Product name or type:
FreeStyle Mini® and FreeStyle® Blood Glucose Monitoring Systems

Reference:
SN2014(06)

Manufacturer Or Supplier:
Abbott Diabetes Care

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 FreeStyle Mini® Blood Glucose Meters and FreeStyle® Blood Glucose Meters may give erroneously low blood glucose results and may produce out of range control solution results when using FreeStyle Lite® and FreeStyle® Blood Glucose Test Strips.

Background Information Or Related Documents:
Abbott Diabetes Care (UK) has advised that the affected blood glucose meters (FreeStyle Mini® and FreeStyle® Blood Glucose Meters) have been supplied to the Irish market. 

The current issue affects all FreeStyle Mini® and FreeStyle® Blood Glucose Meters when used with any FreeStyle test strip lots (refer to attached FSN). Affected meters were placed on the Irish market between January 2004 and September 2007. Abbott Diabetes Care (UK) has confirmed that the above meters are the only affected meters supplied to the Irish market and no adverse incidents related to this issue have been reported for the Irish market. 

A previous Safety Notice (SN2013(14)) issued by the IMB on 4th December 2013 advised that certain lots of FreeStyle Lite® Blood Glucose Test Strips may give erroneously low blood glucose results when using FreeStyle Mini® and FreeStyle® Blood Glucose Meters – see attached FSN.

FreeStyle Mini® and FreeStyle® Blood Glucose Monitoring Systems Document

Actions To Be Taken:
Advice for End Users / Patients: 

1. Follow the manufacturer’s instructions outlined in the attached FSN and contact Abbott Diabetes Care Customer Service on 1800 776633 for a replacement meter.

2. Ensure that you can continue to monitor your blood glucose appropriately. This should be done in consultation with your healthcare professional. 

3. Pay special attention to signs and symptoms of high blood sugar (hyperglycemia). Symptoms may include excessive thirst, excessive urination, blurred vision, weakness, nausea, vomiting and abdominal pain. If you are 
experiencing any of these symptoms or are not feeling well, contact your healthcare professional immediately. 

Advice for Healthcare Professionals / Pharmacists / Distributors: 

1. Follow the manufacturer’s instructions outlined in the attached FSN and contact Abbott Diabetes Care Customer Service on 1800 776633 for replacement meters. 

2. Ensure that end users who dispose of affected blood glucose meters can continue to appropriately monitor their blood glucose. 

3. Ensure that the appropriate personnel are made aware of this notice and the attached FSN. Please also pass this notice and the attached FSN on to any end user or organisation where the potentially affected blood glucose meters have been transferred.

Further Information:
Enquiries to the manufacturer should be addressed to: 

Barbara Scott 
Abbott Diabetes Care 
4051 Kingswood Drive 
Citywest Business Campus 
Dublin 24 

Telephone: 1800 776633 
E-mail: ADChelpuk@abbott.com 

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
 
Please click here to view a copy of the 1st FSN

Please click here to view a copy of the 2nd FSN

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

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