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Logbook Reorder

LifeScan Malaysia

SureStep Plus

A Letter to LifeScan Customers
URGENT: MEDICAL DEVICE RECALL
SureStep™ Plus Meters To Be Replaced

Replacement of SureStep™ Plus Meters with Serial Numbers between
L3152Rxxxxxx and L5348Rxxxxxx

18th April 2006

LifeScan, Inc. is replacing specific SureStep™ Plus Meters due to a possible issue with the meter’s display. If you use, recommend, distribute or sell a SureStep Plus Blood Glucose Meter, please read the following important information so that you can determine if your meter is affected and how to receive an appropriate replacement meter at no charge.

Certain SureStep Plus Meters are More Likely to Develop Display Problems

The SureStep Plus Meter has a display that shows test results and other important information. This display is made up of "segments" that are turned on and off to form letters and numbers.

Over time, the segments in any Liquid Crystal Display (LCD) can fail. For this reason, all SureStep Plus Meters have a built-in display check and come with an owner’s booklet that contains instructions on how to check the display when turning the meter on.

Recently, LifeScan has found that segments in the displays of certain SureStep Plus Meters may fail at a rate that is higher than expected. This failure 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.

What You Should Do

  1. Check your meter’s serial number.
  2. Call LifeScan if your meter’s serial number is in the affected range.
  3. If your meter is not in the affected range, please be sure to check the display before each test.

1. Check your meter’s serial number

SureStep Plus Meters with serial numbers between L3152Rxxxxxx and L5348Rxxxxxx are more likely to have a problem with segments in the display. Please check the serial number on the back of your meter immediately to find out if it is in this range. (See Figure 1 below on how to check the serial number.) If you have trouble finding or reading your meter serial number, please call OneTouch World Services at 1800 801 497 (during office hours) to find out if your meter is affected.

How to check the serial number on the back of the SureStep Plus Meter

Serial Number in circled area —>
(example)

Serial Number
Figure 1

2. Call LifeScan if your meter’s serial number is in the affected range

LifeScan will replace all SureStep Plus Meters with serial numbers between L3152Rxxxxxx and L5348Rxxxxxx. If you have a SureStep Plus Meter with a serial number in this range or if you have trouble finding or reading your meter serial number, please call the OneTouch World Services immediately at 1800 801 497 (during office hours) to confirm you have an affected meter and to receive a replacement meter. While we will not be able to provide you with another SureStep Plus Meter, we will make arrangements with you to have an appropriate replacement meter sent to you at no charge.

Until your replacement meter arrives, you should continue to use your current meter, as long as the display is working properly.

3. Check your meter’s display before every test
It is very important that you check the display before each test. (See the instructions below.) If you ever find that the display is not working properly, do not use the meter and call OneTouch World Services back immediately at 1800 801 497 (during office hours) for assistance.

How To Check Your SureStep Plus Meter's Display

To check that all display symbols are working, press and release the blue power button. The whole display will appear for 3 seconds 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 Figure 2 below). A similar picture of a properly working display test can also be found in your SureStep Plus Meter Owner's Booklet.

DISPLAY TEST
DISPLAY TEST EXAMPLE
TEST RESULT EXAMPLE

Properly Functioning Display

Display with Missing Segments

Recognizable Result, but Incorrect

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 8.6 result is really 8.8, as shown by the missing segment in gray.

Figure 2

Keep this Letter and Be Sure To Contact LifeScan

Again, if you have a SureStep Plus Meter with serial numbers between L3152Rxxxxxx and L5348Rxxxxxx, please call the OneTouch World Services at 1800 801 497(during office hours) to receive a replacement meter at no charge. We recommend that you keep this letter with your SureStep Plus Meter as a reference so that you can check your meter’s display before each test. If you have any questions about this issue, please contact LifeScan.

How To Contact LifeScan

OneTouch World Services Toll-Free Number: 1800 801 497 (during office hours)
E-mail: Service@OneTouchAsia.com
Operating Hours: Monday through Friday, 8:30 a.m. - 5:00 p.m

We apologize for any inconvenience this issue may cause, and we thank you for your continued support of LifeScan.

 

OneTouch Meters

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Contact Us

Toll-Free Number:
1800 801-497

Operating Hours:
Mon-Fri,
8:30 am-5:00 pm

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