Urgent Medical Device Correction
SureStep®Pro® Test Strips
For Reference by Healthcare Practitioners Only
February 24, 2010
Frequently Asked Questions:
Has the FDA been made aware of this issue?
Yes, the FDA has been made aware.
Is this a recall?
LifeScan is taking a field action to provide additional information to our hospital customers regarding how to safely use the product. At this time, we are not replacing product, however, LifeScan is aggressively working on making the necessary corrective actions to address this issue.
Is the FDA forcing you to do this?
LifeScan proactively approached the FDA with a plan that included an ‘Urgent Medical Device Correction’ letter. This plan was accepted by the FDA and is now being implemented by LifeScan.
What meters and strips does this affect?
This issue affects SureStep®Flexx®, SureStep®Pro® and OneTouch® SureStep® Hospital meters using the SureStep®Pro® test strips.
Does this notification affect all SureStepPro test strips?
This affects recently manufactured SureStepPro test strips. Lots with expiration dates from 04/30/2011-05/31/2011 may be impacted.
Lots with expiration dates of 06/30/2011- 10/31/2011 are impacted. Please contact your sales representative or LifeScan’s customer service at
800 218-0221 for exact lot numbers affected.
Why is the SureStep Consumer test strips a Recall and the SureStepPro Test Strips a Field Notification?
As consumers generally do not have easy access to getting a laboratory draw for a clinical lab test or alternate blood glucose meter to verify glucose results and because a root cause fix has not yet been determined, LifeScan decided to voluntarily convert these consumers to the OneTouch Ultra Brand Meters which use an entirely different technology and is used by the majority of LifeScan customers.
Hospitals and clinics that use SureStepPro test strips have protocols and procedures in place in addition to access to alternate testing methods in the event a glucose result is in excess of 400mg/dL. HCPs will likely treat these patients with insulin and are tested frequently. These frequent testing intervals could alert HCPs about blood glucose levels that are above the reportable range
How do I set my Upper Limit Critical High to 400mg/dL on my SureStepFlexx or SureStepPro blood glucose meters?
Please see the “Instructions for Adjusting the Critical High Limit” page or consult your DataLink System Administrator’s Guide. These guides are all found online at http://www.lifescan.com/professionals/resources.
What exactly is going on with the performance of the strip?
We have determined that recently manufactured SureStep®Pro® Test Strips (used by all three of these systems) may provide falsely low test results when the blood glucose is greater than 400 mg/dL. If this occurs, a result is displayed instead of “High” or “Hi.” For example, a blood glucose level of 650 mg/dL may be displayed by the SureStep System as 469 mg/dL instead of “High or “Hi.”
How do I know my results are accurate? (How do I know I can trust my results up to 400mg/dL?)
LifeScan has completed extensive internal testing and we are confident results between 0-400mg/dL are accurate.
What steps are you taking to ensure this issue does not happen again?
We have extensive quality systems and procedures in place to thoroughly investigate each issue. We are working hard to identify the root cause and will notify our customers when this issue is resolved.
When is this issue going to be resolved?
We are working hard to identify the root cause of this issue and will notify our customers when this issue is resolved.
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