URGENT: MEDICAL DEVICE CORRECTION
Labeling Change for the OneTouch® UltraSmart™ Meter
July 14, 2005
If you use, recommend, distribute or sell the OneTouch® UltraSmart™ Meter, we want to make you aware of a difference between how a specific feature of the meter operates and how it is described in the Owner's Booklet and Quick Reference Guide.
With test results from 1.1 through 3.3 mmol/L, Fig. 1 the meter is designed to display the message "Do you need a snack?" beneath the blood glucose test result.
However, the Owner's Booklet and Quick Reference Guide state that this message will appear when blood glucose results are between 1.1 and 3.9 mmol/L.
Continue Testing With The OneTouch UltraSmart Meter
Users can continue to test their blood glucose with the OneTouch UltraSmart Meter. This updated information has no impact on the accuracy of test results. The meter is performing correctly when it displays the "Do you need a snack?" message at blood glucose levels from 1.1 through 3.3 mmol/L. We recommend that OneTouch UltraSmart Meter users print this notice and keep it with their meter's instructional materials for future reference.
Patients should contact their healthcare professional if they have questions regarding the appropriate treatment for blood glucose results below their target range.
If you have questions about this notice or the OneTouch UltraSmart Meter, please contact LifeScan.
How To Contact LifeScan
Call Customer Care on FREEPHONE:
0800 121200 (UK)
1800 535676 (Ireland)