Voluntary recall for VerioIQ, VerioPro and Verio Pro+ meters

[Administrator]

Lifescan has announced a voluntary recall for OneTouch® Verio® IQ, OneTouch® Verio® Pro and the OneTouch® Verio® Pro+ meters.

Why: At extremely high glucose levels (56.8 mmol/L and above), the meters will not operate as intended, which could potentially delay the diagnosis and proper treatment of severe hyperglycemia.

LifeScan, Inc., the manufacturer of OneTouch® Verio® Meters, is initiating a voluntary recall and replacement of its OneTouch Verio Pro, OneTouch Verio IQ, and OneTouch Verio Pro+ blood glucose meters in the UK and Ireland, effective immediately.

LifeScan is recalling and replacing all OneTouch Verio Pro, OneTouch Verio IQ, and OneTouch Verio Pro+ meters because at extremely high blood glucose levels of 56.8 mmol/L and above, the meters do not operate as intended. This could lead to incorrect treatment or delay proper treatment of extreme hyperglycemia, potentially resulting in serious injury.

While the likelihood of experiencing an extremely high blood glucose level of 56.8 mmol/L or higher is rare, when such a blood glucose level occurs, it is a serious health risk requiring immediate medical attention.

“The safety of our patients is our highest priority,” said Michael Pfeifer, M.D., LifeScan’s Chief Medical Officer. “When we learn that a product does not fully meet our expected standards, we will voluntarily notify our regulators, customers and patients and take corrective action. We regret any difficulties these actions may cause; however, we will always err on the side of caution and act in the best interests of our patients.”

Actions that LifeScan are taking

Notifications are being sent to all registered users, healthcare professionals, pharmacies and distributors wherever these products are sold. LifeScan estimates that there are approximately 22,000 active users of the OneTouch® Verio Pro, OneTouch Verio IQ, and OneTouch Verio Pro+ meters. LifeScan is in the process of implementing an update to the meters; however, the timing to resume shipments has not yet been determined.

LifeScan has notified and is working with the individual regulatory agencies around the world where these products have been sold. 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. The company has not determined whether the OneTouch® Verio®Pro meter was a causal factor.


Q & A About the Voluntary Recall for VerioIQ, VerioPro and Verio Pro+ meters

Which meters are affected?

The meters affected are the OneTouch Verio Pro, the OneTouch Verio Pro+ and the OneTouch Verio IQ.

What is the fault?

OneTouch Verio IQ

At extremely high blood glucose levels of 56.8 mmol/L and above, the meter will turn off instead of displaying the message “EXTREME HIGH GLUCOSE above 33.3 mmol/L” as intended.

OneTouch Verio Pro

At extremely high blood glucose levels of 56.8 mmol/L and above, the meter will display and store in memory an incorrect test result that is 56.8 mmol/L below the measured result.

OneTouch Verio Pro+

At extremely high blood glucose levels of 56.8 mmol/L and above, the meter will display the correct message but store in memory an incorrect test result that is 56.8 mmol/L below the measured result.

What do I need to do and which replacement meter will I get?

OneTouch Verio IQ

You can continue to test with your current meter while you wait for your replacement meter to arrive. If your meter unexpectedly turns off and enters set-up mode after turning it back on, your blood glucose may be extremely high, and you should call your health care professional.

Please call LifeScan Customer Service at 0800 279 9118 (UK) or 1800 535 676 (Ireland) to verify your meter Serial Number and confirm your address so that they may send you a replacement Verio IQ meter as soon as it is available. LifeScan will also send a padded bag for you to send back your current meter.

OneTouch Verio Pro

You should discontinue use of this meter immediately and use another meter for testing your blood glucose.

Please call LifeScan Customer Service at 0800 279 9118 (UK) or 1800 535 676 (Ireland) to verify your meter Serial Number and confirm your address so that they may send you a replacement meter. LifeScan will send a temporary meter that uses OneTouch Ultra test strips such as the OneTouch Ultra 2 or the OneTouch UltraEasy. They will send a new meter using the OneTouch Verio test strips as soon as it is available. LifeScan will also send a padded bag for you to send back your current meter.

OneTouch Verio Pro+

Healthcare professionals can continue to test with this meter while they wait for the replacement meter to arrive. However, it is important that you do not rely on test results stored in the results log to make patient treatment decisions as they may be inaccurate.

This product is not available to patients with diabetes for personal blood glucose testing. Healthcare professionals should contact LifeScan Customer Service at 0800 279 9118 (UK) or 1800 535 676 (Ireland) to verify the OneTouch®Verio®Pro+ Meter Serial Number and confirm the address so that a corrected, replacement meter can be shipped as soon as possible.

Will I need to change my prescription?

OneTouch Verio IQ

No, you will not need to change your prescription. LifeScan will send you a replacement Verio IQ meter as soon as it is available.

OneTouch Verio Pro

The temporary replacement meters will require you to get your prescription changed to OneTouch Ultra test strips until the updated meters, using the OneTouch Verio test strips, are sent out. LifeScan will provide some extra Ultra test strips, and a prescription change form.

Do I have to send back my meter?

If your meter is a OneTouch Verio Pro, you will need to return your meter. If your meter is a OneTouch Verio IQ, you may choose to keep your meter but only if you are aware that the meter shutting down could be the result of a blood glucose level above 56.8 mmol/l.

Will I get my old meter back?

LifeScan will send you a new meter without the fault over the coming weeks. The company are keen to get new meters out to everyone affected as quickly as possible.

Can I contact LifeScan?

LifeScan UK’s customer care team can be reached on 0800 121 200

Where can I find out more?

You can find out more by clicking the following link: http://www.diabetes.co.uk/news/2013/Mar ... 58795.html

 

[Sid Bonkers]

Re: Voluntary recall for VerioIQ, VerioPro and Verio Pro+ me

Thanks for the heads up on this recall, I have always found that my IQ always reads higher at any level than any other meter I have used and after phoning the recall number above the OneTouch agent I spoke to told me that this recall will fix that too.

And to anyone else who has one of the affected meters I was told that OneTouch will be contacting ever user within the next few days anyway so there may be no reason to call them now.

Obviously if you dont hear within the said "few days" then give them a ring

ps. they said they would be sending out a complete new kit - so more free strips :thumbup: :thumbup: :thumbup:

 

[BaliRob]

Re: Voluntary recall for VerioIQ, VerioPro and Verio Pro+ me

Here we go again - no contact numbers or email addresses for overseas users. Their email address servers block/return overseas email connections.

 

[victorhill]

Re: Voluntary recall for VerioIQ, VerioPro and Verio Pro+ me

blimy
if i had blood sugars pver 20 i would be adjusting insulin to gert them back down to under 10
if they are in the high say above 30 i would feel rubbish .
or am i missing the point
happy easter littte bit of choc boost but also a insulin boost the keep under control

vic

 

[Norton]

Re: Voluntary recall for VerioIQ, VerioPro and Verio Pro+ me

One touch are the worst meters i ever tried in terms of accuracy.
This is only a fact that i've always noticed. They are really pretty but.. We need to trust in those values!
For me it's the end for one touch.. :thumbdown:

 

[Tommy's Nana]

Re: Voluntary recall for VerioIQ, VerioPro and Verio Pro+ me

Its the end for me too for one touch, I received my letter on 18th April about the recall. I rang with my serial number on 19th. A week later still no replacement meter, I rang again and waited another week, Rang again to be told they had run out of strips for the replacement meter. Oddly enough it arrived the next day. I was diagnosed last October so am still a newby, but have studied alot and learnt loads. I want to be in control and not let it control me. I was doing really well but this meter problem has left me so worried that I now have 4 meters and check on each. one I bought recently the strips are £28.00! I don't test with all 4 meters each time though!! I have had a chat with my dn because my onetouch read 'contol solution when it was blood, and I had a severe hypo (I passed out) at 6.5!!!! I felt faint and expected my meter to read 2 ish as I have had readings of 4 and felt ok..... was so shocked at the reading. I do not trust this anymore. I had the hypo (my first one) due to being prescribed metfomin as well as the insulin to help with weight gain, and told to reduce by 2 units which I did, 4 days later I was unconcious.

anyway not all doom and gloom I now have a lovely selection of meters to choose from and get strips for my favourite one from GP.

Good luck everyone

 

[Sid Bonkers]

Re: Voluntary recall for VerioIQ, VerioPro and Verio Pro+ me

..............Recall Update.............

Rang again this morning to say that I had not yet received a replacement meter to be told that they would be sending out a new meter when they have been produced but couldnt tell me when that would be!!! He did say that they werent dangerous, to which I asked "then why are they being recalled"? he answered that they are only inaccurate when reading over 53 mmol/L!!! Has anyone ever had a reading over 53 mmol/L? When I mentioned that my Verio IQ had always read at least 1 to 2 mmol/L over any other meters he said he would get someone to phone me and check it out!! This again seems strange if it cant be replaced what is the point of "checking it out"....

I said it was a bit strange that a meter was recalled and two months later none had been replaced and he was very nice but basically said he was sorry but couldnt tell me when the new meters would be ready and be despatched, when pushed re days? weeks? months? again he said he couldnt say but it shouldnt be long.

Now it seems to me that if something is faulty and potentially dangerous enough for a recall to be announced then the ability to accurately tell your customers when they will receive their new replacement meters would be of paramount importance if only to alleviate any worries that their consumers may have, so saying that they dont know when this replacement will even be ready seems incredible to me bearing in mind this thread is nearly two months old and apparently not one meter has yet been replaced, how can they not know when the new replacement models will be ready?

What do you think, am I being a bit harsh or should they have pulled out all the stops to get new replacements out to their customers?

 

[jackie21123]

Re: Voluntary recall for VerioIQ, VerioPro and Verio Pro+ me

Ive been waiting for over 8 weeks and still no meter, and the meter us for my 9 year old and they told me we should receive it within 2-3 weeks.

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