Alerta De Seguridad para Commercial name: Cobas e 411 and Elecsys 2010 analyzer. Technical name: Biochemical Analyzer. ANVISA registration number: 10287410608. Risk class: I. Model affected: N / A. Serial numbers affected: Not applicable.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Cobas and 411 customers: The actual manufacturer of the product, Hitachi High Technologies Corporation (HHD, will fix this error in the Sample & Control; data file with a new software version.) This new software will prevent samples from being requested and executed on the cobas and 411 when the Sample & Control data file is full Distribution by the manufacturer of the next version of the software is scheduled for the fourth quarter of 2017. Roche Diagnostica recommends performing the following actions until the new SW is installed: • Perform the "Sample Data Cleai "Sample Data Clear" is step 2 in the Workflow Guide in the "System Overview" window. Note: Cleaning the sample data eliminates all sample results and transfers the QC data to the QC viewing window. It is recommended to perform the backup procedure regularly, depending on the vo and its local regulations. If your system is connected to a server, verify that all data has been loaded before performing sample data cleaning. • When the new SW version is available, it must be installed as a mandatory update on the system. Elecsys 2010 Customers: Roche Diagnostica recommends performing the following actions daily: • Delete open, unprocessed or unordered samples (if appropriate) on the "Order" screen • Exclude documented samples from the "Result" ) If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (EA) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. If you are a professional or an Institution / Entity, if you are a professional of an institution / entity, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option. access through the link - Date of identification of the problem by the company: 06/21/2017 - Date of notification notice to Anvisa: 07/20/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Causa
    Roche diagnostics gmbh, the legal manufacturer of the product, informs its customers and users that, in very rare cases, software malfunction (sw) may occur in the sample & control data file; (revision of results) and may cause a potential incompatibility of data. this sw malfunction only occurs: • when the "sample data clear" function is not performed daily as indicated in the operator's manual, and • when the sample & control; and • when the elecsys 2010 analyzer's sample & contro; / (revision of results) data file is occupied with> 600 records.
  • Acción
    Field Action Code SBN-CPS-2017-011 released under the responsibility of Roche Diagnostica Brasil Ltda. You will upgrade the Software.