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Science/Tech See other Science/Tech Articles Title: FreeStyle InsuLinx Glucose Meter Voluntarily Recalled in United States Abbott is voluntarily recalling its FreeStyle InsuLinx blood glucose meters in the United States due to a malfunction that could lead to a delay in the identification and treatment of severe hyperglycemia or incorrect treatment being given, which could potentially lead to serious injury or death. The problem is occurring at extremely high blood glucose levels of 1024 mg/dL and above, says the company. When this happens, the FreeStyle InsuLinx 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). The company is notifying all registered users, healthcare professionals, pharmacies and distributors where the FreeStyle InsuLinx Meter is sold. Abbott estimates that there are approximately 50,000 active FreeStyle InsuLinx Meter users in the United States. Upon identifying the issue, Abbott notes it promptly developed and implemented an update to the meter. This move follows a similar recall, last month, by the LifeScan unit of Johnson & Johnson, which voluntarily recalled almost 2 million of its OneTouch Verio blood glucose meters because they malfunctioned at extremely high blood glucose levels. Customers who are using the FreeStyle InsuLinx meter should immediately take one of the following actions to address this issue with their meter, Abbott says: They can access a software update to resolve the issue at www.freestyleinsulinx.com/swupdate. This update will allow them to maintain settings and historical data on their meter. Customers can contact Abbott Diabetes Care Customer Service at 1-866-723-2697 to expedite return and replacement of their FreeStyle InsuLinx meter at no charge. Replacements are available, and Abbott will send meters to customers immediately upon request. The company is advising that the current FreeStyle InsuLinx meter may be used until customers are able to update the meter software or until a requested replacement meter arrives. But if patients experience symptoms that are not consistent with their readings, they should contact their healthcare professional and follow his or her treatment advice. Although blood glucose levels at 1024 mg/dL and above are very rare, if they do occur they are a serious health risk and require immediate medical attention, Abbott stresses. "Our first priority is to safeguard the health and safety of patients," said Heather Mason, senior vice president, diabetes care, at 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." No other Abbott blood glucose meters are affected by this issue. FreeStyle Meter Also Marketed in Europe and Australia To date, there has been 1 reported patient incident in the United States that may be related to this specific issue. The patient sought medical treatment and was diagnosed with hyperglycemia, treated, and released. It has not been determined that the FreeStyle InsuLinx meter was the cause, the company notes. Outside the United States, there have been no patient incidents reported related to this specific issue. The FreeStyle InsuLinx meter is also available in Australia, Belgium, Canada, France, Germany, Israel, Italy, the Netherlands, Spain, Switzerland, and the 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 US Food and Drug Administration and all relevant healthcare authorities in the other countries and 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. Post Comment Private Reply Ignore Thread
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