At extremely high blood glucose levels, the meter will not provide a warning
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LifeScan, is recalling and replacing all of its OneTouch Verio IQ blood glucose meters in the United States.
At extremely high blood glucose levels of 1024 mg/dL and above, the meter will not provide a warning that the blood glucose is extremely high and will shut off, thereby potentially leading to incorrect treatment and delaying proper treatment.
The company says that while the likelihood of experiencing an extremely high blood glucose level of 1024 mg/dL or higher is remote, when such a blood glucose level occurs, it is a serious health risk requiring immediate medical attention. Because these products do not provide an appropriate warning at that level, diagnosis and treatment of extreme hyperglycemia may be delayed or incorrect treatment may be given resulting in potentially serious health risk or fatality.
Patients who are using the OneTouch® Verio®IQ Meter should:
- Contact LifeScan Customer Service at (800) 717-0276 to make arrangements to receive a replacement meter at no charge and to speak with a LifeScan representative. Representatives are available 8 a.m. to 10 p.m. EDT Monday through Sunday (LifeScan U.S. Customer Service).
Patients may continue to test with their OneTouch Verio IQ Meters while they wait for their replacement meter to arrive as long as they are aware of this issue. However, LifeScan advises that if the meter unexpectedly turns itself off during testing, this could be a sign of extreme hyperglycemia requiring immediate medical attention and the patient should call a healthcare professional.
Notifications are being sent to all registered users, healthcare professionals, pharmacies and distributors wherever these products are sold. LifeScan estimates that there are approximately 90,000 active OneTouch Verio IQ Meter users in the U.S.
In the U.S., this recall affects the Verio IQ blood glucose meter from OneTouch. To date, no adverse events or patient injuries related to this specific issue have been reported. All other OneTouch blood glucose brands sold in the U.S., including OneTouch Ultra Meters, OneTouch Select Meters and OneTouch Verio Test Strips, are not affected.
Outside the U.S., this recall affects three Verio blood glucose meters from OneTouch. Three OneTouch Verio Brand Meters are being recalled outside the U.S. because of incorrect glucose value display or record storage at extremely high glucose levels.
These include the OneTouch Verio IQ, OneTouch Verio Pro and OneTouch Verio Pro+ Brands. To date, no adverse events or patient injuries related to this issue have been reported globally for the OneTouch Verio IQ and OneTouch Verio Pro+ Meters. For the OneTouch Verio Pro Meter, LifeScan has received one report of a serious adverse event, which occurred outside the United States. The company has not determined whether the OneTouch Verio Pro Meter was a causal factor.
