FOR IMMEDIATE RELEASE - Apri1 15, 2013 - Abbott today announced it is initiating a voluntary recall of FreeStyle lnsulinx® Blood Glucose Meters in the United States.
The company has determined that at extremely high blood glucose levels of 1024 mg/dL and above, the FreeStyle lnsulinx Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result. For example, at a blood glucose value of 1066 mg/dL, the meter will display and store a value of 42 mg/dL (1066 mg/dL - 1024 mg/dL = 42 mg/dL). No other Abbott blood glucose meters are impacted by this issue.
Blood glucose levels at 1024 mg/dL and above are very rare. However, if high blood glucose levels of 1024 mg/dL and above do occur, they are a serious health risk and require immediate medical attention. As the FreeStyle lnsulinx Meter can display an inaccurate low result at a blood glucose level above 1024 mg/dL, there may be a delay in the identification and treatment of severe hyperglycemia, or incorrect treatment may be given. This could lead to serious injury or death.
Customers who are using the FreeStyle lnsulinx Meter should immediately take one of the following actions to address this issue with their meter:
Until customers are able to update the meter software or until a requested replacement meter arrives, the current FreeStyle lnsulinx meter may be used; however, if patients experience symptoms that are not consistent with their readings, they should contact their healthcare professional and follow his or her treatment advice.
"Our first priority is to safeguard the health and safety of patients," said Heather Mason, Senior Vice President, Diabetes Care, Abbott. "We are committed to ensuring that our customers are able to continue to test their blood glucose with confidence, and we initiated this voluntary recall to ensure our products continue to meet the highest standards of quality and safety. We regret any inconvenience this action may cause."
The company is notifying all registered users, healthcare professionals, pharmacies and distributors where the FreeStyle lnsulinx Meter is sold. Abbott estimates that there are approximately 50,000 active FreeStyle lnsulinx Meter users in the United States. Upon identifying the issue, Abbott promptly developed and implemented an update to the meter.
To date, there has been one reported patient incident in the United States that may be related to this specific issue. The patient sought medical treatment, was diagnosed with hyperglycemia, treated and released. It has not been determined that the FreeStyle lnsulinx Meter was the cause.
Outside the United States, there have been no patient incidents reported related to this specific issue. The FreeStyle lnsulinx meter is available in Australia, Belgium, Canada, France, Germany, Israel, Italy, Netherlands, Spain, Switzerland and United Kingdom. Customers in these countries can get more information about how to address this issue by visiting www.freestyleinsulinx.com/swupdate.
Abbott has notified the U.S. Food and Drug Administration and all relevant healthcare authorities in the other countries. Abbott is working with the individual regulatory agencies around the world where the affected products have been sold.
Additional information about this recall can be found at https://www.abbottdiabetescare.com/press-room/2013/2013-c.html or by calling 1-866-723-2697.
Abbott Diabetes Care, based in Alameda, Calif., is a leader in developing, manufacturing and marketing glucose monitoring systems designed to help people better manage their diabetes. Additional information about Abbott Diabetes Care may be found at www.abbottdiabetescare.com.
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people.
Visit Abbott at www.abbott.com and connect with us on Twitter at @AbbottNews.