Abbott just announced a recall of its FreeStyle lnsulinx® Blood Glucose Meters in the United States, the U.S. Food and Drug Administration said.
Abbott discovered 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 instance, if a blood glucose value of 1066 mg/dL is obtained, the meter will incorrectly 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, although rare, do occur and signal a serious health risk that requires 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, or the incorrect treatment, of severe hyperglycemia, which could lead to serious injury or death.
Customers using the FreeStyle lnsulinx® Meter should immediately take one of the following actions:
- Access the software update at www.freestyleinsulinx.com/swupdate. This update will allow customers to maintain settings and historical data on their meters.
- Contact Abbott Diabetes Care Customer Service, toll-free, at 1.866.723. 2697 to expedite return and replacement of the 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, patients who experience symptoms inconsistent with their readings should contact their healthcare professional.
The company is notifying all registered users, healthcare professionals, pharmacies, and distributors where the FreeStyle lnsulinx® Meter is sold. Abbott estimates approximately 50,000 active FreeStyle lnsulinx® Meters are used in the U.S.
One reported patient incident has been reported in the U.S. that may be related to this specific issue. The patient sought medical treatment, was diagnosed with hyperglycemia, was treated, and was released.
The FreeStyle lnsulinx® 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 receive additional information on how to address the recall issue by visiting www.freestyleinsulinx.com/swupdate.ng.
Abbott stated that it has advised the FDA and all relevant healthcare authorities in countries outside of the U.S., is collaborating with countries outside of the U.S., and is working with individual regulatory agencies globally where the recalled products have been sold.