Events

Alerta De Seguridad para ARCHITECT SYSTEM / ARCHITECT SYSTEM. Anvisa Record: 10055311134. Affected Model: c8000 (with the following software versions: 2.20, 2.20DB, 2.60, 3.10, 3.11 and 3.12).

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Abbot Laboratories; Abbott Laboratórios do Brasil Ltda – Divisão Diagnósticos..

¿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
    947
  • Fecha
    2008-11-03
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 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
    According to Abbott Ltd, good laboratory practice with respect to sample handling can minimize the occurrence of the suction error in the pressure monitoring (Error Code: 3375), thereby reducing the incorrect suction potential of the subsequent sample. Some causes of Error Code 3375 are as follows: (1) Presence of fibrin when a sample is centrifuged prior to complete clot formation; (2) Presence of bubbles, foam or clot in the sample; (3) Inadequate sample volume in sample or tube cuvette; (4) Presence of particulate matter, fibrin or blood cells in stored samples. The Technovigilance Unit is following up on this case.
  • Causa
    The architect c8000 system software can allow the required tests for one sample to be aspirated from a different sample under different conditions. the defect can occur when an aspiration error (error: 3375 - unable to process test, aspiration error occurred) is generated during the test.
  • Acción
    Abbott Laboratories of Brazil Ltda has already initiated a corrective action, aiming to update the versions of software under risk by an updated version (version 3.13). According to company information, corrective action has already been reported to customers through FA-11. Until the software update is performed, the following actions are required for users of the product: Configure your ARCHITECT system to ensure that the results are not released by the laboratory until: (1) it is verified that no samples have been flagged with Error Code 3375; or (2) until the retests for those samples that have submitted Error Code 3375 are completed. This can be achieved in two distinct ways: (1) Retention of the result transmission in the ARCHITECT System Control Center - SCC); (2) Retention of the transmission of results in the middleware (Distributed Computing System) or LIS. For more details, see the Required Actions item described in the Letter to Customers (http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/947_carta.pdf). To access the Verification Form, see http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/947_formulario.pdf

Device

ARCHITECT SYSTEM / ARCHITECT SYSTEM. Anvisa Record: 10055311134. Affected Model: c8000 (with the ...

Manufacturer

Abbot Laboratories; Abbott Laboratórios do Brasil Ltda – Divisão Diagnósticos.
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    ANVSANVISA