Events

ADVIA CHEMISTRY XPT SYSTEM 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Siemens Healthcare Diagnostics Inc. || Jeol Ltd. 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
    I1511-516
  • 사례 연번
    2015DM-0013005
  • 날짜
    2015-11-06
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=167
  • 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 affirms that it has identified several faults that may affect the workflow, among which are the reestablishment of the printing control, automatic archiving and erasing failed, restart of workstations, failure to communicate with the laboratory information system (lis) and re-establishment of calibration intervals, leading to the potential occurrence of incorrect calculations and adverse events due to poor sample treatment.

Device

ADVIA CHEMISTRY XPT SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    ADVIA CHEMISTRY XPT SYSTEM with software version 1.0.3
  • 제품 설명
    The ADVIA CHEMISTRY XPT SYSTEM instrument is an automated analyzer for clinical chemistry or blood chemistry tests that processes tests in serum, plasma, urine or cerebrospinal fluid in random access mode and by series with a production rate of 1800 pho- totometric tests per hour and 600 tests of electrolytes (ISE) by now. Performs colorimetry, enzymatic, puntofinal, kinetic, selective ion for electrolytes. Of continuous random access. Uses urine, serum or plasma samples for in vitro diagnostic tests (IVD) of enzymes, biochemistry, cardiovascular, oncology, anemia, electrolytes, etc. It is in automated system that reports the values of the tests and communicates the results of clinical of the patient.
  • Manufacturer
    Siemens Healthcare Diagnostics Inc. || Jeol Ltd.

Manufacturer

Siemens Healthcare Diagnostics Inc. || Jeol Ltd.
  • Source
    NIDFSINVIMA