Notice Information: - Advisory - 24/07/2012

Title:

Blood glucose meters and Test Strips

Product:

Blood glucose meters and Test Strips

Reference:

SN2012(10)

Manufacturer / Supplier:

Various

Target Audience:

Pharmacists supplying these devices
General Practitioners
Healthcare professionals who use these devices
Healthcare professionals managing patients who use these devices
General public
Risk Managers
Procurement Managers
Carers

Please bring this safety notice to the attention of all who need to be aware of it.

Issue:

The correct unit of measurement for blood glucose monitoring in Ireland is mmol/L. The IMB is aware that some Test Strips being procured from outside Ireland and placed on the Irish market have the control solution range stated in the unit of measurement mg/dL instead of mmol/L.

Background Information / Related Documents:

The correct unit of measurement for blood glucose monitoring in Ireland is mmol/L. The IMB is concerned that the unit of measurement for the control solution range provided with some blood glucose test strips being procured from outside Ireland and supplied to the Irish market, is mg/dL instead of mmol/L. In this scenario, although the values for the control solution range provided are correct, for the unit of measurement mg/dL, blood glucose meters in Ireland may provide a result outside the range because they read in the mmol/L unit of measurement. Users may reject the test strips which may result in a delay in treatment or users making a treatment decision in the absence of a glucose result.
The instructions for use that are provided with blood glucose test strips and the operator manuals provided with blood glucose meters clearly outline the importance of checking the unit of measurement.

Action to be taken:

Procurement Managers
• If you purchase glucose Test Strips which originate from outside Ireland,
ensure that the control solution range stated on the label is in mmol/L.

Healthcare professionals:
• If you prescribe / supply or use these devices ensure that the correct unit of
measurement for blood glucose monitoring in Ireland is used (mmol/L).

• Advise patients that the correct unit of measurement for blood glucose
monitoring in Ireland is mmol/L.

General public:
• The correct unit of measurement for blood glucose monitoring in Ireland is
mmol/L. 

The IMB has also published an Information leaflet on safety tips for blood glucose meters. Please see the Information leaflets section on the Publications page of the IMB website. 

Medical devices information leaflet - safety tips for blood glucose meters

Further Information:

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

Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2

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

Please click here to view PDF version of this Safety Notice