Events

ADVIA 560 and 360 HEMATOLOGY SYSTEM 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Diatron Mi Plc || 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
    I1704-128
  • 사례 연번
    2015DM-0013266
  • 날짜
    2017-04-03
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=94
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer reports that the referenced medical devices can obtain multiple discordant records for the same sample id, which may result in a misinterpretation of the complete data, blood count values, appropriate follow-up and / or delay in testing, leading to their being presented adverse events on patients.

Device

ADVIA 560 and 360 HEMATOLOGY SYSTEM
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    The ADVIA 560 AND 360 HEMATOLOGY SYSTEM is a fully automated, high quality hematology system for use in in vitro diagnostics in clinical laboratories. The system uses the impedance method for the measurement of leukocyte (WBC), erythrocyte (RBC) and platelet (PLT) concentrations. The hemoglobin concentration (HGB) of red blood cells is measured by photometric refraction. The system provides a differential measurement of the leukocyte formula of 5 parts of WBC (LYM%, MON%, NEU%, EOS%, BAS%) by laser-based optical flow decitometer technology. The ADVIA 560 and the ADVIA360 HEMATOLOGY SYSTEM identify patients with hematological parameters inside and outside the established reference ranges. The system can process up to 100 μl of blood completely anticoagulated, automatically for hematology.
  • Manufacturer
    Diatron Mi Plc || Siemens Healthcare Diagnostics Inc

Manufacturer

Diatron Mi Plc || Siemens Healthcare Diagnostics Inc
  • Source
    NIDFSINVIMA