Abbott Diabetes Care: Class 1 Recall - FreeStyle InsuLinx Blood Glucose Meters - Risk of Incorrect Test Result

[Posted 05/20/2013]

AUDIENCE: Risk Manager, Patient, Health Professional

ISSUE: Abbott initiated a voluntary recall of FreeStyle lnsulinx Blood Glucose Meters in the United States. At extremely high blood glucose levels of 1024 mg/dL and above, the FreeStyle InsuLinx Blood Glucose Meter will display and store in memory an incorrect test result that is 1024 mg/dL below the measured result. Blood glucose levels at 1024 mg/dL and above are very rare. However, if high blood glucose levels of 1024 mg/dL and above occur, they are a serious health risk that requires immediate medical attention.

BACKGROUND: The FreeStyle InsuLinx Blood Glucose Meter measures sugar (glucose) in blood drawn from the fingertips of people with diabetes to monitor blood sugar levels. On April 15, 2013, Abbott Diabetes Care sent an Urgent Product Recall letter to all its affected customers. The FreeStyle InsuLinx Blood Glucose Meters were distributed from April 18, 2012 through April 1, 2013.

RECOMMENDATION: Consumers who are using the FreeStyle InsuLinx Meter should immediately take one of the following actions to address this issue with your meter:

• Access a software update to install on your meter to resolve the issue at: www.freestyleinsulinx.com/swupdate. The software update will allow you to maintain settings and historical data on your meter.
• Contact Abbott Diabetes Care Customer Service at 1-866-723-2697 to expedite return and replacement of your FreeStyle InsuLinx meter at no charge. Replacements are available, and Abbott will send a meter to you immediately upon request.

Healthcare professionals who have FreeStyle InsuLinx Blood Glucose Monitoring Kits are advised to immediately discontinue dispensing them to your patients, and to arrange for product return and replacement, call Abbott Diabetes Care customer service at 1-866-723-2697.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[05/20/2013 - Recall Notice - FDA]
[04/15/2013 - Firm Press Release - Abbott]