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
    I1604-176
  • 사례 연번
    2015DM-0013266
  • 날짜
    2016-04-29
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=144
  • 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 has identified that after its use erroneous results can be obtained, since they do not indicate the following flag: the warning flag for low sample volumes (w) and the flags of morphology that indicate the presence of immature granulocytes (g) and atypical lymphocytes (g) , which could lead to potentially adverse events on patients due to diagnostic errors.

Device

ADVIA 560 and 360 HEMATOLOGY SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    ADVIA 560, serial S020202, S020201, S020200 and S020197, with software version 4.1.2133
  • 제품 설명
    The ADVIA 560 and 360 HEMATOLOGY SYSTEM are 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 deleucocyte concentrations (WBC), erythrocytes (RBC) and platelets (PLT). The concentration of hemoglobin (HGB) of the red blood cells semide by photometric refraction. The system provides a differential measurement of the WBC 5-part leukocyte formula (LYM%, MON%, NEU%, EOS%, BAS%) by laser-based optical flow cytometry technology. The ADVIA 560 and the ADVIA 360 HEMATOLOGY SYSTEM identify patients with hematological parameters within and outside the established reference ranges. The system can process up to 100 ul of whole blood that is agicoagulated, automatically for hematology.
  • Manufacturer
    Diatron Mi Plc || Siemens Healthcare Diagnostics Inc

Manufacturer

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