Events

INNOVASTAR and RESPONS 910/920 and BIOMAJESTY 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Diasys Diagnostics Systems Gmbh 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
    I1502-78
  • 사례 연번
    2012DM-0008452
  • 날짜
    2015-02-20
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=185
  • 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 states that a software anomaly under certain circumstances may result in invalid patient test results, this if a multi-point calibration is performed with one of the expired calibrators but the restoratives are still within their useful life, consequently, the calibration point is not valid it will not be used for the calculation of the calibration curve, but another calibration point will be used twice instead, leading to possible errors in the results of patient sample processing and adverse events.

Device

INNOVASTAR and RESPONS 910/920 and BIOMAJESTY
  • 모델명 / 제조번호(시리얼번호)
    RESPONS 910
  • 제품 설명
    The blood chemistry analyzers INNOVASTAR and RESPONS 910/920 and BIOMAJESTY from DIASYS® laboratory equipment with an automated platform, continuous random access controlled by their software, colorimetric techniques, ISE, nephelometry and enzymatic porinmunoassays for multiple tests for endocrinology, chemistry and immunology , both quantitative and qualitative. Processes urine, fluid, serum or plasma samples for in-vitro diagnostic tests (IVD). The reagents used with the analyzers for INNOVASTAR and RESPONS 910/920 and BIOMAJESTY of DIASYS have respective health records.
  • Manufacturer
    Diasys Diagnostics Systems Gmbh

Manufacturer

Diasys Diagnostics Systems Gmbh