Alerta De Seguridad para Trade Name: Urisys 1100. Technical Name: Instrument for urinalysis. ANVISA Registration Number: 10287410738. Hazard Class: I. Model Affected: N / A. Serial numbers affected: Destruction: UX09612510; UX09628084; UX09631442. Active: UX09656469. Stock: 9629877; UX09627628; 9629878; UX09642188.

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 - Sandhofer Strasse 116 - 68305 - Alemanha.

¿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
    The company informs customers that they are aware of changes in the detection limits of the instructions for use of test strip products for each individual test parameter. Therefore, the following solution needs to be performed until further notice: If Urisys 1100® is reporting negative results for Protein, Nitrite, Ketones, Leukocytes or Blood (intact red cells), check the result by visual reading using the color scale supplied in the vial of test strips. In the case of discrepant values, the visually determined value should be reported. 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 (http: //portal.anvisa / notivisa). To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 04/17/2018 - Date of notification notice for Anvisa: 08/05/2018 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
    The registrant reported that the manufacturer of the product performed performance studies and the alleged performance change for the test strip products combur10test ux (100 tests), combur10test ux (100 tests), combur10test ux, chemstrip 10 a measured at urisys 1100. according to the company, experiments to determine the detection limit revealed divergent values ​​for the current statement of related package inserts. the detection limit values ​​for updated protein, nitrite, ketones, leucocytes or blood (intact erythrocytes) are in the field action notification table sbn-cps-2018-004. informs that the values ​​for all other parameters remain unchanged and that the lower limit of detection for visual reading remains unchanged for all parameters.
  • Acción
    Field Action Code SBN-CPS-2018-004sob responsibility of the company Roche Diagnóstica Brasil Ltda. Updating, correcting or supplementing the instructions for use.