Urgent Medical Device Voluntary Recall – OneTouch® Verio®IQ Meter – March 2013

Just thought I would pass this along.
http://www.onetouch.ca/verioiqrecallnotification

Failure To Provide A Warning At Extremely High Blood Glucose Levels

We have recently determined that at extremely high blood glucose levels of 56.8 mmol/L and above, the OneTouch® Verio®IQ Meter will turn off instead of displaying the message “EXTREME HIGH GLUCOSE (above 33.3 mmol/L)” as intended. When turned back on, the meter enters Set-Up mode and requires the user to confirm the date and time settings before being able to test again. However, if your glucose level is still 56.8 mmol/L or above when testing, the meter will shut down again.

The likelihood of experiencing extremely high blood glucose levels of 56.8 mmol/L and above is remote. However, when they occur, they are a serious health risk and require immediate medical attention. Because the OneTouch® Verio®IQ Meter does not provide the “EXTREME HIGH GLUCOSE (above 33.3 mmol/L)” message at glucose levels of 56.8 mmol/L and above, there may be a delay in the diagnosis and treatment of extreme hyperglycemia, or incorrect treatment may be given. This could lead to serious injury. As a result, we have decided to replace all OneTouch® Verio®IQ Meters at no charge.

Views: 84

Replies to This Discussion

Thanks for posting this Dwayne

Why would I think , the same thing happened last year or in 2011 ??? I had received the meter as a free one and the meter was recalled ...

The topice was mentioned on TV last night , CTV National News , Lisa Laflamme ...it was mentioned, that a previous recall had occured ...see my earlier post response

RSS

Advertisement



REsources

From the Diabetes Hands Foundation blog...

Spare A Rose, Save A Child for Valentines Day

Here’s a new way to celebrate Valentines Day: Buy a dozen roses, spare the cost of one (about $5) and donate to IDF’s Life for a Child program. By doing this, you will help children in need of life saving insulin. Those of Read on! →

Diabetes Hands Foundation Announces Interim Executive Director as Manny Hernandez, Co-Founder and President, Steps Down

Read the Spanish version of the announcement. BERKELEY, CA: January 15, 2015 – Manny Hernandez, President and Co-Founder of the Diabetes Hands Foundation (DHF), has announced his decision to step down as President of the organization. “Diabetes Hands Foundation has Read on! →

Diabetes Hands Foundation Team

DHF TEAM

Melissa Lee
(Interim Executive Director, has type 1)
Manny Hernandez
(Co-Founder, Editor, has LADA)

Emily Coles
(Head of Communities, has type 1)

Mila Ferrer
(EsTuDiabetes Community Manager, mother of a child with type 1)

Mike Lawson
(Head of Experience, has type 1)

Corinna Cornejo
(Director of Operations and Development, has type 2)

Desiree Johnson  (Administrative and Programs Assistant, has type 1)

DHF VOLUNTEERS


Lead Administrator

Brian (bsc) (has type 2)


Administrators

Lorraine (mother of type 1)
Marie B (has type 1)

DanP (has Type 1)

Gary (has type 2)

David (has type 2)

 

LIKE us on Facebook

Spread the word

Loading…

This website is certified by Health On the Net Foundation. Click to verify. This site complies with the HONcode standard for trustworthy health information: verify here.

© 2015   A community of people touched by diabetes, run by the Diabetes Hands Foundation.

Badges  |  Contact Us  |  Terms of Service