Events

N Latex IgM Reagent, 105 Test Kit - Record 10345161169 - Lot 44018 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Products 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
    1499
  • 날짜
    2015-01-21
  • 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 the incremental risk due to the issue associated with an overestimation of the CSF serum IgM ratio was assessed as being low. Determination of IgM in CSF is not affected. The falsely increased CSF / serum IgM Ratio may lead the clinician to believe that a patient has an intrathecal IgM synthesis related to inflammation or infection of the brain, spinal cord, and meninges. This may lead to further unnecessary investigations and / or delay in treatment and may cause temporary or reversible damage.
  • 원인
    Siemens healthcare diagnostics has confirmed claims indicating a potential for falsely low igm results obtained in serum samples using the affected n latex igm batches. evaluation of intrathecal igm synthesis with n latex igm results in serum and cerebrospinal fluid (csf) samples can be obtained from a calibration curve. if an igm (igmcsf / igmsoro) quotient is calculated using a falsely low serum result and if the result is transferred to a reiber diagram, this quotient will be very high and may result in overestimation of a possible intrathecal igm synthesis.
  • 조치
    Customers have been instructed to discontinue use of the product, segregate any remaining stock for Siemens to arrange for collection of these units. In addition, Siemens recommends: • If the affected batches were used to determine the IgM ratio (IgMCSF / IgMsoro) using the Reiber diagram, we recommend that you do the following: i) If the calculated IgM quotient is in the range between the range of the normal upper range and the range + 40% in the Reiber diagram (for details, see Annex - Client Letter), the result can be overestimated due to the falsely low IgM result obtained in the serum sample. ii) We recommend reconsidering the diagnosis of the respective patient considering the clinical history of the patient. iii) In case additional patient results do not support the result of an intrathecal IgM synthesis or inflammation, a re-measurement of samples may be considered using an alternative batch.

Device

N Latex IgM Reagent, 105 Test Kit - Record 10345161169 - Lot 44018

Manufacturer

Siemens Healthcare Diagnósticos Ltda.; Siemens Healthcare Diagnostics Products GmbH