Events

ADVIA Chemistry System 에 대한 현장 안전성 서한

ALIMS (Agencija za lekove i medicinska sredstva)에 따르면, 해당 현장 안전성 서한 는 Serbia 에서 SIEMENS HEALTHCARE DIAGNOSTICS INC. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 날짜
    2013-09-17
  • 사례 출판 날짜
    2013-04-10
  • 사례 국가
    Serbia
  • 사례 출처
    ALIMSA
  • 사례 출처 URL
    https://www.alims.gov.rs/latin/2013/10/04/vazno-obavestenje-o-medicinskom-sredstvu-advia-chemistry-system-model-1200-1800-2400-biohemijski-analizator/
  • 비고 / 경고
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 recall data from the U.S. and Serbia.
  • 데이터 추가 비고
  • 원인
    Siemens healthcare diagnostics manufactures field correction for advia 1200, 1650, 1800 and 2400 chemistry systems. the manufacturer has determined that these calculation test systems produce unmarked results when the results of the individual tests used in the calculation have labels. in cases where the marks suppress the numerical result, no calculation will be made. if a numerical result is generated with the tag, the calculation test will be issued without the tag. the results of the individual tests used to calculate the most common test ratios (eg anion gap, a / g ratio, osmolality and estimated ionized calcium) are of clinical significance and are commonly reviewed and released together with the result of the calculated ratio. however, the% hba1c_3 method can be set to produce only a score for the relationship, which means that if the tests included in the calculation are labeled, they will not be displayed on the end result, potentially leading to an inappropriate assessment of the patient's glucose control.

Device

ADVIA Chemistry System

Manufacturer

SIEMENS HEALTHCARE DIAGNOSTICS INC.