Withdrawal of Onetouch Verio Pro and Verio IQ

olmo's profile photo   04/02/2013 11:04 a.m.

Taking a look at the Madrid diabetic page, I have seen this article ...
In itself you use it here I leave you in link ...

Source: Link ... -verio-iq/

The AEMPS reports the withdrawal of the Onetouch Verio® Pro and Onetouch Verio® IQ glucometers market, manufactured by Lifescan Europe, Switzerland, given the risk of obtaining incorrect results or failure to provide a notice to extremely high blood glucose concentrations.

The Spanish Agency for Medicines and Health Products (AEMPS) has been informed by the company Lifescan Europe, Switzerland, with the withdrawal of the Onetouch Verio® Pro and Onetouch Verio® IQ glucometers market, given the risk of obtaining incorrect results or failure in failure inProvide a notice to extremely high concentrations of blood glucose, which could produce a delay in the diagnosis and treatment of severe hyperglycemia or the administration of incorrect treatment.

Onetouch Verio® Pro and Onetouch Verio® IQ glucometers are designed for use in the quantitative measurement of glucose (sugar) in capillary blood.Health personnel can use venous blood samples.

In the case of the Onetouch Verio® Pro glucometer, the company has detected that at concentrations greater than or equal to 1024 mg/dl, the meter shows and stores in the memory an incorrect analysis result that is 1024 mg/dl lower than the one analyzed.And does not show the message "Glucose very high greater than 600 mg/dl".

Example: a concentration of blood glucose of 1064 mg/dl will generate the following result: 1064 - 1024 = 40 mg/dl.The meter will therefore show a result of 40 mg/dl and will also store this result of 40 mg/dl.

In the case of the Onetouch Verio® IQ glucometer, the company has detected that at concentrations greater than or equal to 1024 mg/dl, the meter goes out instead of showing the message “Glucose much higher than 600 mg/dl”.When the meter is turned on again, it enters the configuration mode, the confirmation of the date and time is required before being able to analyze again.If these glucose levels are maintained, in the following measurement, the meter will go out again.
The probability of presenting high blood glucose concentrations in blood, greater than or equal to 1024 mg/dl is remote.
The Onetouch Verio® Pro glucometer began to be distributed in Spain in February 2011 and the Onetouch Verio® IQ in July 2012 by the company Lifescan Spain (Johnson & AMP; Johnson S.A.), Paseo twelve stars 5-7, Campo de las Nations, 28042 Madrid.

Current situation in Spain
Lifescan has sent notes of warning to the pharmacy offices, health centers and distribution centers, as well as a letter destined for patients, to warn of the problems detected and inform the withdrawal and replacement of these glucometers.

The company has declared this agency that it has not received claims or incidents related to this problem in Spain

affected products

Onetouch Verio® Pro

Onetouch Verio® IQ

Recommendations
Asked the Spanish Diabetes Society, the AEMPS issues the following recommendations:
Patients
If you have a Onetouch Verio® Pro manufactured by Lifescan Europe:
Call the Onetouch Personal Care Line (800 600 889), to verify the data of your Onetouch Verio®Pro meter and confirm your postal address, so that you can send you a replacement meter
.
You can continue analyzing your current Onetouch Verio®Pro meterWhile he hopes his replacement meter will arrive.However, if you observe an abnormally low result when you are experiencing tiredness symptoms, you are thirst or is urinating a lot, this low result may be due to an error in the glucometer operation.In this case, you must go to an emergency service to contact a healthcare professional.

If you have an Onetouch Verio® IQ glucometer manufactured by Lifescan Europe:
Call the Onetouch Personal Care Line (800 600 889), to verify the data of your Onetouch Verio®iq meter and confirm your postal address, so that you can send you a replacement meter.

You can continue to analyze with your current Onetouch Verio®iq meter while you expect your replacement meter to arrive.However, if your meter goes out unexpectedly during the analysis, it could be a sign of extreme hyperglycemia that require immediate medical attention.If your meter goes out unexpectedly, and enters into configuration mode when turning it back on, its blood glucose concentration could be extremely high.In this case, you must go to an emergency service to contact a healthcare professional.
Health professionals from Pharmacy Offices

Identify and maintain in your possession all the glucose meters onnetouch Verio® Pro and Onetouch Verio® IQ that you have among your stocks.
Return these glucometers through your usual channel.

Share this information with patients who use these glucometers and send them to the Onetouch Personal Care Line (800 600 889), to organize the sending of a replacement meter.

Healthcare professionals
Do not supply the Onetouch Verio® Pro and Onetouch Verio® IQ glucose meters to patients and collect and keep all the samples of this meter in their possession.
From Lifescan you will contact you to agree on the collection and replacement of them.You can also contact the Onetouch Personal Care Line for assistance (800 600 889).

Share this information with patients who use these glucometers and send them to the Onetouch personal care line, to organize the sending of a replacement meter.

Distributors
Identify and maintain in your possession all blood glucose meters Onetouch Verio® Pro and Onetouch Verio® IQ that you have among your stocks.
Communicate this replacement program to all its customers.Request that the affected glucometers be returned through your usual channel.
Health professionals can communicate any incident related to the product, according to the procedure established in the guidelines for the application of the surveillance system by the centers and health professionals (Ref.: AEMPS/CTI-PS/October 2010) and the related forms related forms.

Company data
Lifescan Spain (Johnson & Amp; Johnson S.A.)
Walk twelve stars 5-7
Campo de las Naciones
28042 Madrid.
Telephone customer service lifescan: 800 600 889
Link

olmo's profile photo
olmo
04/02/2013 11:04 a.m.
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Thank you very much Olmo !!!
This morning they just given me all the strips of the Verio and because those of the old One Touch are no longer supplied by the health center and I only have 2 boxes!They had given me the verio for a long time to try and stopped working, I called the house and sent me 2 without asking me for the old glucometer as they had done before and it seemed very strange to me but I thought they wanted to heal in health, now I understand whywas.I continued using the old one that goes perfectly.Tomorrow I can't go to the health center! Tonight I don't sleep from the nerves .....
All the best.

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Beky
04/04/2013 8:48 p.m.
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Yesterday I had an appointment with my educator, I told him that I had a glucoto Verio that I had to do, I tell myself that I did not have to worry.The previous day the representative had been with her and what happens to the glucometer is that when it gives values ​​of more than 1024, how many times do you have those values?If you have them you are going to call 112. I tell myself that I could use it normally but to get quieter in ten days she would have there glymeters reviewed by the house and changed it to me.

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manolo82
04/05/2013 5:49 a.m.
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I have not yet been able to locate my nurse but I suppose that knowing something will tell me the same.For me it is no tranquility because it is not me who has the symptoms and I can evaluate what glycemia could have.It is clear that 1024 never have but this apparatus no longer gives me any confidence for this and because in the statement it also puts this other that makes me worry:

You can continue to analyze with your current Onetouch Verio®Pro meter while you expect your replacement meter to arrive.However, if you observe an abnormally low result when you are experiencing tiredness symptoms, you are thirst or is urinating a lot, this low result may be due to an error in the glucometer operation.In this case, you must go to an emergency service to contact a healthcare professional.

Imagine that according to the glucometer it is 40 and then it is in 300 and I give it to overcome well and I cannot contrast the result .......... I will not risk the case, I am clear.Now what I don't know is what you can offer me from other houses with the changes that you have, I have always used this.

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Beky
04/05/2013 8:05 a.m.
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Beky is changing the house directly, they give you another already proven

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manolo82
04/05/2013 10:20 a.m.
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Enter or call the attention phone of Lifescan 800 600 889 and there informs you to change it

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manolo82
04/05/2013 10:28 a.m.
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Thanks Manolo.If I did it a long time ago when they gave me the first and stopped making readings, they sent me two others that are now checking with the Ultrasmart and always gives me upward figures with a difference of between 10-20-30%So I am going to change them because for me they are not very reliable at the time of hypoglycemia, especially at night.
All the best.

By the way, how is Bayer's?Is Countourlink?Thank you.

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Beky
04/09/2013 6:22 a.m.
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