Events

Trade Name: ADVIA Hematology System; 10345161959; Risk class I; Affected Model - ADVIA 560 Hematology System; Number of series affected: S020202, S020201, S020200, S020197. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Inc. 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
    1867
  • 날짜
    2016-04-04
  • 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
  • 원인
    Siemens healthcare has identified that equipment with software version 1.4.2133 does not indicate the following flags: warning flag for low sample volumes (flag w) and morphology flags indicating the presence of immature granulocytes (g) and atypical lymphocytes (l). if the user uses the device with the affected software version, the results may be lower than expected.
  • 조치
    Action code HI 16-01. Initiated by Siemens, it is sent a Letter to the Customer prepared in March 2016 with risk classification III (situation in which there is a low probability that the use or exposure to a health product may cause adverse health consequences). Recommendation to users and patients: To ensure that the patient sample quantity is sufficient to perform the assay, it is recommended to follow the requirements described in the ADVIA 560 Hematology System Operator's Manual. Siemens recommends a review of the abnormal results for white cells , confirming them with the manual differential when necessary.

Device

Trade Name: ADVIA Hematology System; 10345161959; Risk class I; Affected Model - ADVIA 560 Hemato...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Inc.