Urgent Medical Device Recall: OneTouch® SureStep® Test Strips
To find out if your test strips are affected, call LifeScan Customer Service at +632 824-8736 (GMA), 1-800-1-7954 (Toll Free) between 7:30 a.m to 4:30 p.m, Monday through Friday
Urgent Medical Device Notice
OneTouch® SureStep® Hospital Test Strips
OneTouch® SureStep® Test Strips
24 February 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 expected standards.
If you use 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 OneTouch® SureStep® Hospital Test Strips and OneTouch® SureStep® Test Strips (used by both of these systems) may provide low test results when the blood glucose is greater than 500 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.”
To address this issue, we recommend you adjust your “Critical High” protocol threshold to no more than 400 mg/dL. 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.
SureStep® Flexx® Systems
(With OneTouch®DataLink® Software)
OneTouch® SureStep® Hospital System &
SureStep® Flexx® System (Stand Alone Mode)
To adjust the “Critical High” threshold feature of the SureStep®Flexx® Systems when using OneTouch® DataLink® Software, please refer to the enclosed instructions. This information is also found in the Operator’s Guide of each system.
The OneTouch® SureStep® Hospital System and SureStep®Flexx® System (when used in standalone mode) do not have a programmable “Critical High” feature. Please instruct all staff to consider any result in excess of 400 mg/dL as a “Critical High.”
If you need further assistance please contact your local sales representatives or our customer service helpline at +632 824-8736 (GMA), 1-800-1-7954 (Toll Free) between 7:30 - 16:30 Weekdays (Mon - Fri)
We would like to reassure you that no adverse events have been reported in relation to this matter. 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.
