Safety Alerts & Recalls
What does this mean?
Blood glucose levels at 1024 mg/dL and above are very rare. However, if high blood glucose levels of 1024 mg/dL and above do occur, you are at a serious health risk and require immediate medical attention. As the One Touch Verio IQ Blood Glucose Meter and the FreeStyle lnsulinx Meter do not function properly at a blood glucose level above 1024 mg/dL, there may be a delay in the identification and treatment of severe hyperglycemia (high blood glucose levels), or incorrect treatment may be given. This could lead to serious injury or death.
If you have a One Touch Verio IQ Blood Glucose Meter, please call 1-800-717-0276 to speak to a Lifescan representative and make arrangements to receive a replacement meter at no charge. Until you receive your new device you may continue to use your One Touch machine. In the event that your machine shuts down please consult your healthcare professional for help.
Customers who are using the FreeStyle lnsulinx Meter should take one of the following actions to address the issue with their meter:
-- Customers can access a software update to resolve the issue at www.freestyleinsulinx.com/swupdate. The software update will allow customers to maintain settings and historical data on their meter.
-- Customers can contact Abbott Diabetes Care Customer Service at 1-866-723- 2697 to expedite return and replacement of their FreeStyle lnsulinx meter at no charge. Replacements are available, and Abbott will send meters to customers immediately upon request.
-- Until you are able to update the meter software or until a requested replacement meter arrives, the current FreeStyle lnsulinx meter may be used. However, if you experience symptoms that are not inline with your readings, you should contact your healthcare professional and follow his or her treatment advice. Signs of high blood glucose may include increased thirst, frequent urination, headaches, difficulty with concentration, blurred vision and fatigue (weak, tired feeling). If you have any of these symptoms, please contact your doctor and seek medical attention right away.
Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
One Touch Verio IQ and FreeStyle lnsulinx Blood Glucose Meters Recalled
Several manufacturers are recalling some of their blood glucose meters because the machines are not working correctly. The following meters have been recalled: One Touch Verio IQ Blood Glucose Meters from LifeScan/Johnson and Johnson - This machine shuts down in the case of very high sugar levels (above 1024 mg/dL) rather than display the reading and the device will read 'Extreme High Glucose' on readings above 600 mg/dL.
FreeStyle lnsulinx® Blood Glucose Meters from Abbott - 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 example, at a blood glucose value of 1066 mg/dL, the meter will 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 meters are designed for home use for people to self test their blood glucose levels to monitor diabetes.
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