Abbott Diabetes Care

Potential for Serious Injury, Death Prompts FreeStyle InsuLinx Meter Recall

April 18, 2013 04:10 pm News Staff

Abbott Diabetes Care recently announced(www.freestyleinsulinx.com) an urgent, albeit voluntary, recall of its FreeStyle InsuLinx Blood Glucose Meter after discovering that, in some instances, the device displays and stores inaccurate information that could endanger patients' health.

Specifically, the company has determined that at extremely high blood glucose levels (i.e., 1,024 mg/dL and higher), the FreeStyle InsuLinx meter will display and store in memory an incorrect test result that is exactly 1,024 mg/dL below the actual measured result. For example, for a patient whose reading yields a blood glucose value of 1,066 mg/dL, the meter will display and store a value of 42 mg/dL.

Such high readings are quite rare but, if encountered, represent a health emergency that requires immediate medical intervention. A delay in the identification and treatment of severe hyperglycemia or the initiation of incorrect treatment could lead to serious injury or death.

Consumers who use the FreeStyle InsuLinx meter have two options to resolve the issue:

  • They can access a software update(www.freestyleinsulinx.com) that allows them to fix the problem while maintaining the settings and historical data on the current meter.
  • Alternately, they can contact Abbott Diabetes Care Customer Service at (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.

Until users are able to update the meter software or until a requested replacement meter arrives, patients may continue to use the current FreeStyle Insulinx meter, the company said in its announcement. However, if they experience symptoms that are not consistent with their readings, they are being advised to contact their physician and follow his or her treatment advice.

According to a notice on the FDA website(www.fda.gov), one patient incident has been reported in the United States that may be related to this issue. The patient was successfully treated for hyperglycemia and subsequently released. It has not definitively been shown that the FreeStyle Insulinx meter caused the event.

Abbott estimates that there are about 50,000 active FreeStyle Insulinx meter users in the United States. No other Abbott blood glucose meters are affected by this recall.


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