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 Urgent Medical Device Correction SureStep®Pro® Test Strips For Reference by Healthcare Practitioners Only
February 24, 2010 Dear LifeScan Customer: At LifeScan we hold our products to the highest standards of quality; constantly working to ensure they provide glucose results you can rely on. For that reason, we're also committed to communicating with you when we learn of product that does not meet our customers’ expectations. If you use SureStep®Pro®, SureStep®Flexx® or OneTouch® SureStep® Hospital Blood Glucose Monitoring Systems, please read the following important information regarding system performance at high glucose concentrations. At blood glucose concentrations above 500 mg/dL, these systems are designed to display “High” or “Hi” instead of a numerical value to signify that the glucose level exceeds the system’s dynamic range. 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.” If you have an alternate method for point of care blood glucose monitoring, you should consider temporarily discontinuing the use of systems that use SureStep Pro Test Strips until we have replacement product available. If you do not have access to an alternate system, we recommend you adjust your “Critical High” protocol threshold to no more than 400 mg/dL as explained in the boxes below. In addition, all staff should be instructed to confirm via an alternate means or a lab test any result in excess of 400 mg/dL. If the ability to confirm results is not readily available, you can guide preliminary treatment by conducting a clinical assessment.
For assistance with adjusting the critical high limit, please click on the link titled “Instructions for Adjusting the Critical High Limit". If you need further assistance please call our Healthcare Professional Line at 800 218-0221. We are working to address this issue as quickly as possible and will advise you when a solution is available. We apologize for any inconvenience this may cause and thank you for your continued support. Click here to find out if you have test strips with an affected lot. Alternatively, you may call our Healthcare Professional Line at 800 218-0221 and a Technical Service Representative can assist you. Sincerely, LifeScan Customer Service |
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