Events

Preanalytical Equipment for Sample Management - ROCHE 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Roche Diagnostics 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
    I1603-86
  • 사례 연번
    2015DM-0013314
  • 날짜
    2016-02-25
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=155
  • 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 he was notified of a case in which the uncovered sample tubes are not placed correctly back in the rack tube transport (rtt), the open sample tubes were found in the decapper outsorter area, contaminating the equipment with blood , the material of the tubes was spilled and could not be used to carry out the analyzes, leading to potentially adverse events on the patients and reprocesses for the analysis of the samples.

Device

Preanalytical Equipment for Sample Management - ROCHE
  • 모델명 / 제조번호(시리얼번호)
    p512, specific serials.
  • 제품 설명
    The preanalytic system COBAS 8100 and models p512 and p612 is a modular equipment interconnected with each other, for the processing and transport of patient samples in the clinical laboratory. The system has been designed to centrifuge the samples of the patients, remove and insert the tampons, apply the barcode labels and prepare the aliquots with the pipette from the primary samples. You can sort the samples online or off and temporarily store the samples. The system transports the different individualized samples among the cobas analytical modules for immunology, blood chemistry, hematology, hormones, drugs, urine, coagulation and special for the respective laboratory analyzes. The system does not report sample results values, it is not a sample analyzer.
  • Manufacturer
    Roche Diagnostics GMBH

Manufacturer

Roche Diagnostics GMBH