Events

REVISION DATE OF REVISION DIMENSION® Technical Name: REVISED IRRIGATION REAGENT - DIMENSION® ANVISA Registration Number: 10345161043 Hazard Class: II Affected Model: Affected Lot / Series Numbers: BA7006, BA7116, BB7006, DB6267, FD6309 , GB7060 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos S.A; 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
    2095
  • 날짜
    2016-09-30
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • 데이터 추가 비고
    If users receive any complaints of illness or adverse events associated with the product, they should immediately contact the Siemens Customer Support Center or the Siemens technical support representative in their locality.
  • 원인
    Iron dimension and dimension wear a concentration other than that listed in the instructions for use. deferoxamine is cited in the directions for use dimension and dimension vista as a non-interfering substance. the concentration that was used for interference tests (250 ng / dl or 3.8 nmol / l) is significantly lower than expected in clinical practice. siemens healthcare diagnostics sa is providing an update in the section limitations of the instructions for use procedure, iron test for dimension and dimension vista systems, indicating that: patients treated with drugs that bind to metals (eg deferoxamine) may present a reduction in values iron, since the chelating iron may not react adequately in this test. the reference to deferoxamine at a concentration of 250 ng / dl (3.8 nmol / l) will be removed from the section "non-interfering substances" in the instructions for use. the information provided in this release, related to deferoxamine, replaces the information contained on this substance in the current ferro operating instructions for the dimension and dimension vista systems until their respective operating instructions are updated.
  • 조치
    Field Action Code VC 16-07 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send Letter to the Client.

Device

REVISION DATE OF REVISION DIMENSION® Technical Name: REVISED IRRIGATION REAGENT - DIMENSION® ANVI...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Inc.