At extremely high blood glucose levels (56.8 mmol/L and above), the
OneTouch® Verio®IQ meter will not provide a warning and will shut off
BURNABY, BC, March 25, 2013 /CNW/ - LifeScan Inc. is initiating a
voluntary recall and replacement for all of its OneTouch® Verio®IQ blood glucose meters in Canada, effective immediately.
LifeScan is recalling and replacing all OneTouch® Verio®IQ meters because at extremely high blood glucose levels of 56.8 mmol/L
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 likelihood of experiencing an extremely high blood glucose level of
56.8 mmol/L or higher is remote; however, 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 glucose levels of 56.8 mmol/L or higher, diagnosis and treatment of
extreme hyperglycemia may be delayed or incorrect treatment may be
given resulting in potentially serious health risks or fatality.
Patients who are using the OneTouch® Verio®IQ meter should:
Contact LifeScan Customer Service at 1(855) 293-5075 to make
arrangements to receive a replacement meter at no charge and to speak
with a LifeScan representative. Representatives are available 9 a.m.
to 8 p.m. EST Monday through Friday (LifeScan Canada Customer Service).
Seek additional information about this recall on the LifeScan Canada
Please note that patients may continue to test with their OneTouch® Verio®IQ meter 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 health care professional.
"Our patients' safety is our number one priority," said Dr. Michael
Pfeifer, LifeScan's Chief Medical Officer. "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."
Notifications are being sent to all registered users, healthcare
professionals, pharmacies and distributors wherever these products are
sold. LifeScan estimates that there are approximately 60,000 active
OneTouch® Verio®IQ meter users in Canada. The company is in the process of implementing
an update to the meter to address the issue, however, the timing to
resume shipments of OneTouch® Verio®IQ meters has not yet been determined.
In Canada, this recall affects the OneTouch® Verio®IQ blood glucose meter from OneTouch®
To date, no adverse events or patient injuries related to this specific
issue have been reported for the OneTouch® Verio®IQ meter. All other OneTouch® blood glucose brands sold in Canada, including OneTouch® Ultra® meters, and OneTouch® Verio® Test Strips, are not affected and can continue to be used with
Outside Canada, this recall affects three OneTouch® Verio® blood glucose meters from OneTouch®
Three OneTouch® Verio® Brand meters are being recalled outside Canada because of incorrect
glucose value display or record storage at extremely high glucose
levels. These meters 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 Canada. The company has not determined whether
the OneTouch® Verio® Pro meter was a causal factor.
LifeScan has notified Health Canada and healthcare authorities around
the world of this voluntary action. LifeScan is working with the
individual regulatory agencies around the world where the affected
products have been sold.
LifeScan Inc. is a leading maker of blood glucose monitoring systems for
people with diabetes. For information about diabetes care and LifeScan
Canada products and services, visit www.onetouch.ca.
Trademarks owned by Johnson & Johnson and used under licence. ©2013
LifeScan Canada Ltd AW 101-179A
SOURCE: LifeScan Canada Ltd.
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