Events

Dimension Lipase 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 Siemens Healthcare Diagnostics GmbH 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
    2017-12-22
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    Siemens healthcare diagnostics has received customer complaints regarding a positive bias in qc results and patient samples when using dimension® lipl flex® lot fb8109. siemens internal investigation has confirmed the positive bias with lipl lot fb8109 when compared to other dimension lipl lots. lot fb8109 is not meeting siemens internal specifications for lot-to-lot limits. the investigation compared lot fb8109 with control lot gb8141 (historical performance representative dimension lipase lot). the lot comparison between dimension lipl lot fb8109 and lot gb8141, when using patient samples, demonstrated an average positive bias of 15%. the range of positive bias of 11% (1028 u/l using lot gb8141, as reference lot vs 1141 u/l using lot fb8109) to 22% (94 u/l using lot gb8141 as reference lot vs 114 u/l using lot fb8109). see graph 1 for lot comparison data. .

Device

Dimension Lipase
  • 모델명 / 제조번호(시리얼번호)
    Dimension® clinical chemistry system Positive Bias When Using Lipase (LIPL) Assay Lot FB8109
  • Manufacturer
    Siemens Healthcare Diagnostics GmbH

Manufacturer

Siemens Healthcare Diagnostics GmbH