Urgent Medical Device Correction

Important Notice!

Last Updated: December 19, 2005

URGENT: MEDICAL DEVICE CORRECTION

Precision Xtra (original version) and MediSense® Optium

 

Dear Abbott Diabetes Care Customer:

In an effort to keep you better informed about Abbott Diabetes Care blood glucose monitoring products and to reinforce the product labeling we are providing the following information. This information pertains to the products listed above and pictured below. To help ensure you continue to obtain accurate blood glucose results, we ask that you review the following important information.

This letter is to inform you of an important subject regarding the proper use of these Abbott Diabetes Care blood glucose meters. For Precision Xtra, only the single button model pictured below is affected. The three-button (new and improved) Precision Xtra model is not affected. Additionally, no test strips are affected by this correction. In an effort to ensure that you continue to obtain accurate blood glucose results, we ask that you review the following important information.

The Abbott Diabetes Care meters have a display window that shows test results and other important information. The display window is made up of "segments" that are turned on and off to form letters and numbers. Recently, we found that in certain 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 not functioning properly, it is possible that it will show a letter or number value that you could misinterpret or that you can't read. Therefore, as indicated in the product labeling, it is important to test your meter every time it is started to ensure that all segments of your meter are functioning properly as outlined in the owner's manual. Although this condition has occurred in less than 0.35% of these meters, based on customer complaints, we are proactively notifying you to ensure your meter is working properly.

 

Please review the following to confirm that your meter has all display segments working properly.

1. Press the "power" button on the meter and hold.
2. The meter will turn on and display screen should be illuminated for approximately three (3) seconds. The meter will display three characters shaped like the number 8 as shown below. There should be a decimal point between each () character

   

3. Please review each character () to ensure all segments are displayed.
4. If all segments of each character are shown, please continue to use your meter.
5. If there is a segment or segments from any of the characters not displayed or missing, please discontinue use and call Customer Care for a free new meter at 1-877-844-4399.

We at Abbott Diabetes Care want to thank you for your continued support of our products. This correction is intended to ensure that you have the utmost confidence in the results you obtain. Should you have any questions, please contact Customer Care at 1-877-844-4399.

 

DOC08842-Rev-A 12/06