Events

RAPIDPoint 500 SYSTEM, Hazard Class I, Registration: 10345161877, Serial numbers: 33897; 34218; 34225; 34227; 34497; 34502; 34515; 34516; 34607; 34608; 34611; 34974; 34975; 34977; 34982; 34986; 34990; 35096; 35097; 35098; 35664; 35666; 35667; 35669; 35671; 35672; 35680; 35724; 35726; 35728; 35729; 35979; 36044./////. RAPIDLab 1200 SYSTEMS, Model: RAPIDLab 1265, Registration: 10345160455, Serial numbers: SEE ANNEX. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos Ltda.; 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
    1518
  • 날짜
    2015-01-29
  • 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
    According to data from the manufacturer the health risk related to this issue is limited to the delay in the detection of hyperbilirubenia, while the result is confirmed by biochemical tests if the value found is lower than expected. If you get a result that is greater than expected, phototherapy would already be started and any change in therapy would require confirmation by laboratory biochemical tests.
  • 원인
    Siemens healthcare diagnostics reported a change in the measurement of the neonatal bilirubin parameter (nbili), which may have a variable increase when the concentration of nbili is> 12mg / dl (205 μmol / l) and the thb concentration exceeds the reportable range greater than 25 g / dl (15.5 mmol / l). when this occurs, the analyzer may report results of nbili greater or less than expected.
  • 조치
    Siemens advises customers to perform the procedures described below, and to wait for the company to be scheduled for correction and to file the letter with the laboratory files: • If your analyzer reports "----- ↑" in the result of tHb, and the nBili result is reported, do not release the nBili result reported by the analyzer. • Please review the letter with the Clinical Director of your Laboratory. • Fill in and return the Effective Verification Form attached to the letter to the customer within 7 days. /// (SEE LETTER TO THE CUSTOMER IN ANNEX)

Device

RAPIDPoint 500 SYSTEM, Hazard Class I, Registration: 10345161877, Serial numbers: 33897; 34218; 3...

Manufacturer

Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Inc.