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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
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