The company said it will be recalling and replacing more than 2 million of the units worldwide.
At very high blood glucose levels above 1024 mg/dL, the meter fails to provide a warning and shuts itself off, which can lead to improper or delayed treatment.
It is extremely uncommon for blood glucose levels to reach 1024 mg/dL or above, however, if it does it can pose very serious health risks. As the devices do not give proper readings to those with such high glucose levels, it poses a serious problem in the diagnosis and treatment of extreme hyperglycemia, which can be fatal.
Those who use the OneTouch® Verio®IQ Meter should immediately make arrangements to receive a new and fully functioning meter by contacting LifeScan Customer Service at (800) 717-0276.
The OneTouch® Verio®IQ Meter can turn off when glucose levels are very high
The company says that people can continue to use their current meters until they receive their replacement. However, if the device turns off upon testing, it could be an indicator of extreme hyperglycemia, which requires immediate medical attention.
As of yet there have been no reported patient injuries related to the faulty device in the U.S.
Dr. Michael Pfeifer, LifeScan's Chief Medical Officer, said:
"Our patients' safety is our number one priority. When we learn that a product does not fully meet our expected standards, we will voluntarily notify our customers and patients and take corrective action. We regret the inconvenience these actions may cause. However, we will always err on the side of caution and make a decision that is in the best interest of our patients."
LifeScan is sending messages to all users, healthcare professionals, and distributors where the devices are sold. The company estimates that there are close to 90,000 people in the U.S. who use the device. They have revealed that they are currently updating the meters to fix the problem, but the release date is not yet certain.
In 2010, the company had to make a similar recall with their OneTouch® SureStep® Test Strips which provided falsely low glucose results when glucose levels were higher than 400 mg/dL.
Written by Joseph Nordqvist