AEROSET® Biochemical Analyzer and Accessories - Registry Number: 10055310865 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Abbott Laboratórios do Brasil Ltda 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
    792
  • 날짜
    2004-04-16
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 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
    When these error codes occur, the user is notified by changing the color of the icon in the Error Code screen. Lower level error codes (that is, level 3 error messages), as defined by the manufacturer, may have an influence on the generation of patient outcomes. Higher error code levels will cause not only the color change of the icon, but will also cause a change in the processing status of the RUNNING AEROSET Analyzer to PAUSE. The user should evaluate the error code and take the necessary steps to finalize the processing before reporting the results. There is no effect on the health or ability of the user to use the equipment. This occurrence was identified internally during the development of user needs for a next generation of AEROSET Family Member equipment on 6 February 2004. As part of the system review for continuous improvements, the error message database was the appropriate levels setting. When one of the Error Messages listed in Table 1 is generated, an "HW" Result Error Code will be generated. Until your laboratory is able to complete the actions required above, follow these steps: Customer Letter accompanied by Response Protocol for the sole AEROSET customer in Brazil. If you have any questions or concerns, please contact the Abbott Customer Service Center ¬Division Diagnostics - Telephone 0800-11-9099.
  • 원인
    The aeroset® biochemical analyzer and accessories and their software are performing performance as designed and in accordance with the product labeling. as part of an internal system review for continuous improvement, the database of error codes was revised to the levels of error codes configured on february 6, 2004. a total of 18 level 3 error codes were identified as required for reclassification to a higher level, level 1. these levels of error codes are used to determine how the equipment communicates with the end user when error messages occur.
  • 조치
    Customer Letter accompanied by Response Protocol was sent to all AEROSET customers, providing instructions to the user on how to change the status of the error codes identified in Table 2 above. These modifications to the error codes will be included in the next release of the AEROSET Analyzer Software version 1.03ER000, eliminating the need for users to manually change the status of error codes using the above mentioned instructions. The projected date for release of this software is the 4th quarter of 2004

Manufacturer