ADVIA Chemistry Systems A1c_3 calibrator 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Siemens Healthcare Diagnostics 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
  • 날짜
    2014-08-22
  • 사례 출판 날짜
    2014-08-22
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: siemens advia chemistry systems a1c_3 calibrator medical device manufacturer, siemens healthcare diagnostics, has issued a medical device safety alert concerning its advia chemistry systems a1c_3 calibrator [catalogue no.: 10491408 & lot no.: 3hd044; 3ld068]. the manufacturer is conducting a recall of the advia chemistry systems a1c_3 calibrator lots 3hd044 and 3ld068. the manufacturer has confirmed that the advia chemistry systems a1c_3 method may exhibit a percent bias of -9% to +11% for hemoglobin (hb)a1c samples when using a1c_3 calibrator lots 3hd044 and 3ld068. depending on quality control limits, this issue may not have been detected. note: the percent bias range is a percentage of the hba1c result. it is not absolute hba1c units. according to the manufacturer, a percent bias of up to +11% may be considered clinically significant at clinically relevant hba1c ranges between ~5.5% and 8.0%, and may result in the modification of the therapy for hyperglycemia. the modification of hyperglycemic therapy can increase the risk of occurrence of hypoglycemia, which may be observed through personal glucose monitoring and/or patient symptoms. affected users are advised to discontinue use of and discard the affected products. the manufacturer is not recommending a general look back for the laboratory for previously generated results when using these calibrator lots. the manufacturer is also providing a physician letter with retesting guidance for physicians. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 aug 2014.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Siemens ADVIA Chemistry Systems A1c_3 calibrator
  • Manufacturer

Manufacturer