Diabetes Self-Management Blog

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.

POST A COMMENT       
  

Comments
  1. There are no comments at this time.


Post a Comment

Note: All comments are moderated and there may be a delay in the publication of your comment. Please be on-topic and appropriate. Do not disclose personal information. Be respectful of other posters. Only post information that is correct and true to your knowledge. When referencing information that is not based on personal experience, please provide links to your sources. All commenters are considered to be nonmedical professionals unless explicitly stated otherwise. Promotion of your own or someone else's business or competing site is not allowed: Sharing links to sites that are relevant to the topic at hand is permitted, but advertising is not. Once submitted, comments cannot be modified or deleted by their authors. Comments that don't follow the guidelines above may be deleted without warning. Such actions are at the sole discretion of DiabetesSelfManagement.com. Comments are moderated Monday through Friday by the editors of DiabetesSelfManagement.com. The moderators are employees of R.A. Rapaport Publishing, Inc., and do not report any conflicts of interest. A privacy policy setting forth our policies regarding the collection, use, and disclosure of certain information relating to you and your use of this Web site can be found here. For more information, please read our Terms and Conditions.


Tools & Technology
Bionic, Man… (01/30/14)
Insulin Pump Cartridge Recall (01/23/14)
Potential A1C Test Alternative; Glucose Meter Recall (01/21/14)
FDA Approves First-Generation Artificial Pancreas System (10/04/13)

Diabetes News
Overweight People With Type 2 May Benefit From Gastric Banding (04/11/14)
FDA Panel Votes in Favor of Inhalable Insulin; Diet Drug Recalled (04/09/14)
Good News About Good Diabetes Self-Management (03/28/14)
Diabetes Developed at Midlife May Affect Brain Function in Old Age (03/21/14)

Diane Fennell
Overweight People With Type 2 May Benefit From Gastric Banding (04/11/14)
FDA Panel Votes in Favor of Inhalable Insulin; Diet Drug Recalled (04/09/14)
Good News About Good Diabetes Self-Management (03/28/14)
Diabetes Developed at Midlife May Affect Brain Function in Old Age (03/21/14)

 

 

Disclaimer of Medical Advice: You understand that the blog posts and comments to such blog posts (whether posted by us, our agents or bloggers, or by users) do not constitute medical advice or recommendation of any kind, and you should not rely on any information contained in such posts or comments to replace consultations with your qualified health care professionals to meet your individual needs. The opinions and other information contained in the blog posts and comments do not reflect the opinions or positions of the Site Proprietor.


Carbohydrate Restriction: An Option for Diabetes Management
Some people find that decreasing the amount of carbohydrate they eat can help with blood glucose control. Here’s what to know about this approach.

Insulin Patch Pumps: A New Tool for Type 2
Patch pumps are simpler to operate than traditional insulin pumps and may be a good option for some people with Type 2 diabetes who need insulin.

How Much Do You Know About Vitamins?
Learn what these micronutrients can and can’t do for you.

Complete table of contents
Get a FREE ISSUE
Subscription questions