Events

ADVIA Chemistry XPT Technical Name: Biochemical Analyzer ANVISA Registration Number: 10345161947 Hazard Class: II Affected Model: ADVIA Chemistry XPT Affected Batch / Serial Numbers: CA1275001020102; CA1275001600160; CA1275001630163 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
    2096
  • 날짜
    2016-09-12
  • 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
    In order to avoid any possibility of inconsistent ISE results due to disconnected electrodes, make sure that the electrodes are fully connected after replacement, washing or maintenance activities by performing ISE calibration and processing of Quality Controls. If the electrode is not connected properly, the calibration will fail and the operator should perform the usual troubleshoot procedures. Perform the 2 levels of Quality Control at least once a day to confirm the perfect performance of the system.
  • 원인
    It is possible that the ise module will exhibit discrete unbonded results for sodium, potassium and chlorine when the respective electrode (including the reference electrode) remains switched off after replacement, washing or maintenance activities. the calibration and the 2 levels of quality control will fail if the electrode stays off. the instructions for use (ifu) for the ise electrodes clearly state the need to calibrate the ise after the replacement and processing of the two levels of control before testing the patient samples. after the special maintenance - wash, the online help documentation clearly informs the need to calibrate and process controls.
  • 조치
    Field Action Code CHI 15-03 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will notify the client.

Device

ADVIA Chemistry XPT Technical Name: Biochemical Analyzer ANVISA Registration Number: 10345161947 ...

Manufacturer

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