Alerta De Seguridad para ACCU CHEK PERFORMA - Registration with Anvisa nº 10287410617

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.

This situation is restricted to samples of neonates (born up to 28 days) when blood glucose tests are performed with this system and compared with other glucose monitors. In results below 50mg / dl (or 2.8mmol / L), results with negative deviation (lower values) were identified from -7 to - 12 mg / dl (-0.4 to -0.7mmol / L). Internal investigations are being conducted by the company in order to determine the reasons that lead to this deviation of performance. #### 15/10/2010 - After the investigations, the optimized product reached all acceptance criteria, in order to meet all necessary requirements for neonatal dosing. Starting with the 321001 test strip lot, all ACCU-CHEK Performa strips will include the improved calibration process, with performance characteristics for capillary, venous, arterial, and neonatal specimen.VIDE APPENDICES ####