The meter may provide an inaccurate reading
of ConsumerAffairs
Abbott is recalling FreeStyle lnsulinx Blood Glucose Meters in the United States.
The company says that at extremely high blood glucose levels of 1024 mg/dL and above, the 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 affected.
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.
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.
Customers who are using the FreeStyle lnsulinx Meter should immediately take one of the following actions:
- Access a software update to resolve the issue at www.freestyleinsulinx.com/swupdate. The software update will allow customers to maintain settings and historical data on their meter.
- Contact Abbott Diabetes Care Customer Service at 1-866-723- 2697 to expedite return and replacement of their FreeStyle lnsulinx meter at no charge. Replacements are available, and Abbott will send meters to customers immediately upon request.
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.
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.
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.