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Another Blood Glucose Meter Recalled
April 19, 2013
On April 15, 2013, Abbott voluntarily issued a recall of all FreeStyle Insulinx blood glucose meters in the United States because the meter malfunctions at extremely high blood glucose levels. (LifeScan, Inc., recently recalled all OneTouch VerioIQ blood glucose meters in the United States over a similar issue.)
At blood glucose levels of 1024 mg/dl or above, the meter will display and store in its memory a reading that is 1024 mg/dl below the measured result. For a blood glucose level of 1066 mg/dl, for example, the meter will display and record a reading of 42 mg/dl. As Abbott notes, experiencing such a high blood glucose level is unlikely, but it is a serious health risk and requires immediate medical attention should it occur.
Those who are using the FreeStyle Insulinx are advised to take one of the following actions:
• Access a software update at http://www.freestyleinsulinx.com/swupdate/indexus.html that will resolve the issue and allow users to maintain the settings and history on their meters.
• Contact Abbott Diabetes Care customer service at (866) 723-2697 for a free, expedited return and replacement of the meter.
Customers can continue to use their FreeStyle Insuxlinx until their replacement meter arrives, but should immediately contact a health-care professional if they experience symptoms that are not consistent with the meter’s results.
To date in the United States, there has been one reported incident that may be related to this issue, in which a person sought medical treatment, was diagnosed with hyperglycemia (high blood glucose), treated, and released. It has not been determined that the FreeStyle Insulinx meter was the cause of this incident.
Approximately 50,000 people in the United States use the FreeStyle Insulinx meter. The meter is also available in Australia, Belgium, Canada, France, Germany, Israel, Italy, the Netherlands, Spain, Switzerland, and the United Kingdom. No other Abbott Diabetes Care products are affected by this issue.
Abbott has notified the FDA and health-care authorities around the world of the voluntary recall.
For additional information, see the press release on the Abbott Diabetes Care Web site.
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