Events

cobas u 601 / cobas u 701 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 Roche Diagnostics 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
    2017-12-21
  • 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
    With this notification we would like to inform you about the possible sample mismatch within one rack. the analyzer may not transport the rack correctly, so that tubes might be detected twice. as a consequence, the same tube barcode label is read twice and the last tube barcode label is interpreted as the rack id. hence, a sample mismatch is possible between samples processed on the same rack, because the tubes are pipetted in the order given by the rack position and the test result assigned to the wrong sample id. the sample id read twice is thus listed in duplicate in the sample order list and test result list. the orders/test results have different rack ids. the consecutive sample id’s are also affected, since they are listed only once. as a consequence, they have an incorrect rack position displayed. .

Device

cobas u 601 / cobas u 701

Manufacturer

Roche Diagnostics