The AEMPS informs about the risk of obtaining less than real blood glucose values with Lisubel Chek Talk TD4232, manufactured by Taidoc Technology Corporation, Taiwan, if the blood sample is insufficient and emits recommendations aimed at health professionals and patients.
The Spanish Agency for Medicines and Health Products (AEMPS) reports on the risk of obtaining less than real blood glucose values with Lisubel Chek Talk TD4232, manufactured by Taidoc Technology Corporation, Taiwan, when the blood sample in theReactive strip does not completely fill in the confirmation window.
The Lisubel Chek Talk TD4232 glucometer is a blood glucose meter with voice option, which informs and guides through all the options, operations and functionalities of the equipment.Given its accessibility characteristics for blind people and with visual deficiencies, it has been marketed for the control of diabetes, autonomously, by this group.
The Lisubel Chek Talk TD4232 began to be distributed in Spain in October 2009 by the company Laboratories Distrosur, S.A., Pol. Technological Nave 39, 18151 Ogíjares, Granada.
Recently, it has been detected that these glucometers do not have an alarm system that is activated when the blood sample does not completely fill in the confirmation window of the reactive strip, being able to give rise to readings below the real blood glucose values, with the consequent risk of inducing the patient to an incorrect dosage in the administration of insulin.
For the “Lisubel Chek Talk TD4232” glycometer meter to function properly, the blood sample must completely fill in the confirmation window of the reactive strip, for which, the correct/complete filling of said confirmation window must be visually verified.
Current situation
LABORATORIOS DISTROSUR, S.A., at the requirement of the AEMPS, the distribution of the Lisubel Chek Talk TD4232 glucometer has ceased in our country, and has issued a security note to the pharmacy offices, health centers and distribution centers, as well as a letter destinedTo patients, to warn that blind people or with a visual deficiency that does not allow themnormal.
The company will modify the product use instructions to include this warning.These instructions will be delivered to the patients who have the glucometer.
On the other hand, the manufacturer is developing a glucometer with a new technology capable of detecting a poor amount of sample and alerting the user through a notice “Alarm of incorrect sample” “Error”.Likewise, taking into account that in Spain the unit in which blood glucose is usually measured is mg/dl, will eliminate the possibility of using the unit of measure in mmol/l, to avoid a possible involuntary change of the units.Once available, the company will replace the distributed glucometers Lisubel Chek Talk TD4232 with those of the new model.
The company has declared this agency that it has not received claims or incidents related to this problem in Spain.
Recommendations
Health professionals from Pharmacy Offices
If you have in your establishment of the Lisubel Chek Talk TD4232 glucometers manufactured by Taidoc Technology Corporation, Taiwan, remove the products from the sale and contact the company for return.
If you have sold thisProduct to patients, try to identify them to deliver the letter destined for patients.
Health centers and distribution centers
If you have Lisubel Chek Talk TD4232 manufactured by Taidoc Technology Corporation, Taiwan, do not deliver them to patients and contact the company for their return.
If you have delivered Lisubel Chek Talk TD4232 manufactured by Taidoc Technology Corporation to patients:
Contact them to inform them that in the event that they are blind people or with a visual deficiency that does not allow themThe assistance of a person with normal vision.
Hágal delivery of the company letter for patients.
Patients
If you have a Lisubel Chek Talk TD4232 glucometer manufactured by Taidoc Technology Corporation:
In the event that you are blind or have a visual deficiency that does not allow you to verify that the blood sample has completely filled the confirmation window of the reactive strip, do not use it without the assistance of a person with normal vision.
Contact the center that has supplied the product to deliver the company letter for patients and the new instructions for the use of the glucometer, as well as for the subsequent replacement of the glucometer by the new model, when it isavailable.
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
LABORATORIOS DISTROSUR, S.A.
Pol. Technological of Ogíjares, ship 39
18151 Ogíjares, Granada
Telephone: 958 507 360;900 180 675
Fax: 958 507 846
Email: <!