IMPORTANT: MEDICAL DEVICE NOTIFICATION
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IMPORTANT: MEDICAL DEVICE NOTIFICATION July 16, 2009 Dear Valued Customer, It has come to our attention that the FreeStyle Lite test strip lot number mentioned above has the potential to generate low blood glucose readings. These readings are lower than the actual blood glucose concentration. In some instances, the differences between the result from these strips and the actual blood glucose concentration can be large enough to lead to under treatment. Under treatment could result in hyperglycemia and its complications. Symptoms of hyperglycemia can include fatigue, thirst, excessive urination or blurry vision. If you have concerns of hyperglycemia, or if your blood glucose results do not match the way you feel, then please contact your healthcare professional immediately and follow their treatment advice. Our investigation has shown that a small number of vials in lot number 0822524 may contain strips that could produce low blood glucose readings. This issue only affects the above FreeStyle Lite Test Strip Lot Number when used with FreeStyle Freedom Lite and FreeStyle Lite Blood Glucose Meters. Please check the lot number on the test strip carton or vial to see if your strips are from the lot number mentioned above. Information is included at the bottom of this page that shows where to look for the test strip lot number. If the test strips are from the affected lot, please discontinue use immediately, discard the test strips and call Abbott Diabetes Care Customer Care at 1-888-466-0071. The Abbott Diabetes Care representative will arrange to have replacement test strips sent at no charge. If you have any further questions, please call Abbott Diabetes Care Customer Care at 1-888-466-0071. We apologize for any inconvenience this may cause and we thank you for your continued support of Abbott Diabetes Care and the FreeStyle product line. How To Tell If Your FreeStyle Lite Test Strips Are Affected Please check the lot number on the test strips. The lot number appears on the outside of the test strip box and on the label of the test strip vial.
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DOC19391-Rev-B 07/09



