Safety Alert for COMPLETE SYSTEM FOR DETERMINATION AMPEROMETRICADE GLUCOSE LIFESCAN

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

Patients who use these products are advised to contact LifeScan to confirm that their meter is set up in the correct unit of measurement. In Brazil, patients can call the OneTouch Customer Service at 0800 701 5433 or visit www.onetouch.com.br. To better address this issue, LifeScan has temporarily discontinued the release of the Lifescan OneTouch Ultra Complete Glucose Determination System, which allows users to change the unit of measure. LifeScan is implementing a product change for its new OneTouch Ultra meters, which will prevent patients from inadvertently changing units of measurement. ANVISA through the Unit of Technovigilance will be accompanying the actions that will be carried out through the company with respect to the whole process of correction of said product. BRAZIL-15/06/2005 - Update - Lifescan is reviewing the user manual and operating instructions accompanying all related products (reagent tapes and control solution). In addition, although no product claims involving the unit of measurement have occurred in Brazil, all glucose monitors will be fabricated with the function locked for the option of manually changing the unit of measurement from mg / dL to mmo / L. the user will no longer have the option to program his monitor to obtain mmol / L result, which increases the safety of the product and minimizes the possibility of the user misinterpreting the glucose result.