A Letter to LifeScan Customers
URGENT: MEDICAL DEVICE RECALL
OneTouch™ SureStep™ Meters* To Be Replaced
Recall Expanded to Include Monitors with Serial Numbers
between L3152Rxxxxxx and L5348Rxxxxxx
April 30, 2006
LifeScan, Inc. is replacing specific OneTouch™ SureStep™ Meters due to a possible issue with the Monitor's display. This is an expansion of the number of specific Monitors that LifeScan will replace as first identified in the August 31, 2005 letter on www.LifeScan.com/India informing affected users of the issue.
If you use, recommend, distribute or sell the OneTouch SureStep Blood Glucose Monitor, please read and understand this important information so that you can determine if your Monitor is affected and how to receive an appropriate replacement Monitor at no charge.
Certain OneTouch SureStep Monitors Are More Likely To Develop Display Problems
The OneTouch SureStep Monitor 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 OneTouch SureStep Monitors 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 Monitor on.
Recently, LifeScan has found that segments in the displays of certain OneTouch SureStep Monitors 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
- Check your OneTouch SureStep Monitor's serial number.
- Call LifeScan if your Monitor's serial number is in the affected range.
- If your Monitor is not in the affected range, please continue to check the display before each test.
1. Check your Monitor's serial number
OneTouch SureStep Monitors 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 Monitor immediately to find out if it is in this range. (See Figure 1 to check the serial number.) If you have trouble finding or reading your Monitor serial number, please call LifeScan Customer Service between 7 am to 11pm - on all the days - for assistance at 1800225544 to find out if your Monitor is affected.
How to check the serial number on the back of the OneTouch SureStep Monitor
Serial Number in circled area —>
(example) |
 |
|
Figure 1
2. Call LifeScan if your Monitor's serial number is in the affected range
LifeScan will replace all OneTouch SureStep Monitors with serial numbers between L3152Rxxxxxx and L5348Rxxxxxx. If you have a OneTouch SureStep Monitor with a serial number in this range or if you have trouble finding or reading your Monitor serial number, please call the LifeScan Customer Service Line 1800225544 between 7 am to 11pm - on all the days - to confirm you have an affected Monitor and to receive a replacement Monitor. While we will not be able to provide you with another OneTouch SureStep Monitor, we will make arrangements with you to have an appropriate replacement Monitor sent to you at no charge.
Until your replacement Monitor arrives, you should continue to use your current Monitor, as long as the display is working properly. |
3. Check your OneTouch SureStep Monitor's display before every test
It is very important that you check the display before each test. (See instructions.) If you ever find that the display is not working properly, do not use the Monitor and call LifeScan Customer Service between 7 am to 11pm - on all the days - for assistance at 1800225544 .
How To Check Your OneTouch SureStep Monitor's Display
To check that all display symbols are working, press and release the blue power button. The whole display will appear for three seconds when you turn on the Monitor. 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). A picture of a properly working display test can also be found in your OneTouch SureStep Monitor 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. Display is working properly. |
|
Some parts of the display are not working. Message is
incomplete. |
|
In this example, the 120 result is really 420, as shown by the missing
segments in gray. | |
Figure 2
Keep this Letter and Be Sure To Contact LifeScan
Again, if you have a OneTouch SureStep Monitor with serial numbers between L3152Rxxxxxx and L5348Rxxxxxx, please call the LifeScan Customer Service Line to receive a replacement Monitor at no charge. We recommend that you print this notice and keep it with your OneTouch SureStep Monitor as a reference so that you can check your Monitor's display before each test. If you have any questions about this issue, please contact LifeScan Customer Service.
How To Contact LifeScan
LifeScan Customer Service in India
National Toll-Free Line: 1800 22 55 44
E-Mail: Service@LifeScanIndia.jnj.com
Customer Service Hours: 7:00 am to 11:00 pm
(Seven Days a Week)
|
