November 8, 2000

If you use our OneTouch FastTake® Meter (also marketed under the brand names: SmartScan®, EuroFlash® and PocketScan®) to test your blood glucose, recommend it to your patients, or distribute and sell it to customers, please take a few moments to read this important announcement.

The OneTouch FastTake Meter is designed to display test results in either milligrams per deciliter (mg/dL) or millimoles per liter (mmol/L). This is similar to reporting temperature as either Fahrenheit or Celsius.

The standard result measurement in the United States is "mg/dL." The standard in Canada, parts of Europe and some other countries is "mmol/L."

Possible Display Error In Millimole (mmol/L) Setting
A small number of OneTouch FastTake Meters set to "mmol/L" may display test results that show a Y-shaped, non-numeric character in the "ones" position (see the figure below). The Y-shaped character occurs only when the meter is operated in the "mmol/L" units setting.

If you see this Y-shaped character on your meter display please call LifeScan Customer Services and we will advise you of corrective action. Do not interpret the Y-shaped character as a number, for example a "4" or a "9." Do not base any diabetes care decisions on a result that includes this Y-shaped character.

How To Check The Setting Of A OneTouch FastTake Meter
Press the "M" button to quickly check the setting of your OneTouch FastTake Meter.

If your meter is set to "mg/dL:"

In this setting, the OneTouch FastTake Meter will function normally and will not produce the display error. You can continue to use the meter with confidence.

If your meter is set to "mmol/L," it is important that you contact LifeScan Customer Services for assistance so we can advise you of corrective action and, if needed, arrange to provide a future replacement meter (see below for contact information).

Even if you have never seen the Y-shaped character in the "mmol/L"setting, please note that it may appear the next time you change your batteries.

LifeScan Action Plan
LifeScan is fixing the meter's display error as quickly as possible. In addition, LifeScan is launching a comprehensive, worldwide communication program to alert OneTouch FastTake Meter users of this issue. In addition to mailing letters to registered meter owners and healthcare professionals, notifications are also being placed in OneTouch FastTake System Kits and Test Strip boxes. Owner's Booklets and Procedure Guides are also being supplemented with this new information.

How To Contact LifeScan
At LifeScan we know our customers rely on our products to help them manage their diabetes. It's a responsibility we take very seriously. If you need to contact LifeScan regarding this issue please contact us in one of the following ways:

People with diabetes
Telephone: U.S. 800 227-8862; Canada 800 663-5521; Mexico 95 1 800 381-SCAN; for other countries, for other countries, see Around the World.)

E-mail: CustomerService@LifeScan.com

Healthcare Professionals
Telephone: U.S. 800 951-7226, for other countries, see Around the World.)

Retailers/Distributors:
Telephone: 800 600-7226, for other countries, see Around the World.)

Thank you for your continued support of LifeScan.

Please note: No other LifeScan Meters are affected by this issue.

Related Addendums:
You must have Adobe®Acrobat® Reader, available free from Adobe Systems, to read the PDF files.

• Addendum to U.S. OneTouch FastTake Owner's Booklet (xusftobadd.pdf - 198KB)
  (AW 050-495-06A Posted: Nov. 08, 2000)
  

• Addendum to U.S. OneTouch FastTake Test Strip Insert (xusfttsadd.pdf - 167KB)
  (AW 050-495-05A Posted: Nov. 08, 2000)

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