Events

Reflotron Uric Acid, Record: 10287410183, Lots: 20750002, 21149403, 21836402, 21625703, 21506202, 22222403, 22311502, 22500902, 22618503, 22915302, 23179404, 23336508 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Roche Diagnóstica Brasil Ltda.; 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
    1655
  • 날짜
    2015-07-30
  • 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
    The company reports that although erroneous uric acid results are not likely to lead to an immediate serious adverse event, a medical risk due to the low false uric acid results in samples with a hematocrit above 48% can not be ruled out.
  • 원인
    After internal evaluation, roche diagnostics gmbh decided to reduce the hematocrit limit value from 55% to a maximum of 48% for reflotron uric acid products for the measurement of whole patient blood samples. during an internal investigation the manufacturer detected deviations in uric acid results in the reflotron system, which may be above the internal specification of 5% if hematocrit values ​​exceed 48%. this may lead to erroneously low uric acid results in whole blood samples with hematocrit greater than 48%. currently hematocrit values ​​are up to 55% for reflotron uric acid.
  • 조치
    The company informs that a note will be added inside the Reflotron Uric Acid box informing about the reduction of the hematocrit limit value to a maximum of 48%. It further states that this information should be taken into account in measurements of whole blood samples from patients

Device

Reflotron Uric Acid, Record: 10287410183, Lots: 20750002, 21149403, 21836402, 21625703, 21506202,...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH