Events

Safety Alert for ACCU CHEK PERFORMA - Registration with Anvisa nº 10287410617

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Roche Diagnóstica Brasil Ltda..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    971
  • Date
    2009-07-23
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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 ####
  • Reason
    It was observed that when blood samples of neonates were collected by accu chek performa, low blood glucose values ​​were obtained. see clarifications as the termination of alert.
  • Action
    The actions recommended to the users of the product are the following: Immediate interruption of the use of this product in neonates.

Device

ACCU CHEK PERFORMA - Registration with Anvisa nº 10287410617

Manufacturer

Roche Diagnóstica Brasil Ltda.