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Urgent Medical Device Recall: OneTouch® SureStep® Meter

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A Letter To LifeScan Customers:

URGENT: MEDICAL DEVICE RECALL

OneTouch® SureStep® Meter

September 09, 2005

LifeScan is replacing specific OneTouch® SureStep® Meters due to a possible issue with the meter's display. If you use, recommend, distribute or sell the OneTouch SureStep Blood Glucose Meter, please read this important information to determine if you have product subject to recall.

Certain OneTouch SureStep Meters May Develop Display Problems
The OneTouch SureStep Meter has a display that shows test results and other important information. The display is made up of "segments" that are turned on and off to form letters and numbers. Recently, LifeScan found that in certain OneTouch SureStep Meters, these segments may fail at a rate that is higher than expected. This can cause certain letters or numbers in the display to appear incomplete or missing. If the display is failing, it is possible that it will show a test result or a calibration code that you could misinterpret or that you can't read at all.

Over time, the segments in any Liquid Crystal Display (LCD) can fail. These failures usually appear after the meter has been used for long period of time. For this reason, all OneTouch SureStep Meters have a built-in display check and come with instructions to check the display when turning the meter on.

It is very important that you check your meter's display before testing.

What You Should Do
OneTouch SureStep Meters with serial numbers L4266RBxxxx through L5048RBxxxx are more likely to have a problem with the segments in the display. Please check your meter's serial number immediately to find out if it is in this group. You can also call LifeScan Customer Service to find out if your meter is affected.

LifeScan will replace all affected OneTouch SureStep Meters with serial numbers L4266RBxxxx through L5048RBxxxx. Please call LifeScan Customer Service immediately if you have questions or need a replacement meter.

How To Check Your OneTouch SureStep Meter's Display
Until you get your replacement meter, you can still use your current meter, as long as the display is working properly. To check that all display symbols are working, press and hold down the blue power button. The whole display will appear when you turn on the meter. You should carefully look at the display to make sure all "segments" or parts of the display turn on before each test (see pictures).

Compare the working segments in your meter's display with these pictures. A similar picture of a properly working display test can also be found in your OneTouch SureStep Meter Owner's Booklet.

DISPLAY TEST

DISPLAY TEST EXAMPLE

TEST RESULT EXAMPLE

Properly Functioning Display

Display with Missing Segments

Recognizable Result, but Incorrect

All segments are active. The display is working properly.

Some parts of the display are not working. Message will be incomplete.

In this example, the 120 result is really 420, as shown by the missing segments in gray.

Keep This Letter and Be Sure To Contact LifeScan
As a reminder, we recommend that you print this notice and keep it with your OneTouch SureStep Meter. If you have any questions about this issue, please contact LifeScan Customer Service.

How To Contact LifeScan

People with diabetes
Telephone: U.S. 866 461-0094, For all other countries, see Around the World.)

E-mail: CustomerService@LifeScan.com

Healthcare Professionals
Telephone: U.S. 866 461-0043, For all other countries, see Around the World.)

Retailers/Distributors:
Telephone: U.S. 800 600-7226, For all other countries, see Around the World.)

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