Events

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). 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Abbot Laboratories; Abbott Laboratórios do Brasil Ltda – Divisão Diagnósticos. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    947
  • 날짜
    2008-11-03
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    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.
  • 원인
    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.
  • 조치
    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.
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “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