Events

Accu-Chek and CoaguChek 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 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
    2016-01-26
  • 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
    Some accu-chek inform ii base units (bu) and handheld base units (hbu), used for coaguchek professional meters and cobas h232 meters, might produce transmission errors between the meter and the data management system (dms; e.G. cobas it 1000 or any other 3rd party software). the transmission errors present in the form of data loss. this could happen, in rare cases, when the bu/hbu is connected via a usb to a pc. if your bu/hbu is connected via ethernet or if you use wi-fi, you will not experience this issue. if your bu/hbu is connected to a pc via usb, the data loss may cause invalid data exchange. for example, in the case of the accu-chek inform ii meter, this is indicated by numerous messages sent from the meter to the dms in the form of “unexpected sw failure 11800” events. please note that the error message “unexpected sw failure 11800” is quite unspecific. it might have other causes and is therefore no clear indicator for the data loss. .

Device

Accu-Chek and CoaguChek
  • 모델명 / 제조번호(시리얼번호)
    Accu-Chek Inform II Base Unit Handheld Base Unit Handheld Base Unit USA Roche HBU/BU Control Panel Accu-Chek Inform II meter+RF Accu-Chek Inform II meter cobas h 232 cobas h 232 scanner version CoaguChek XS Pro Int'l CoaguChek XS Pro USA CoaguChek XS Plus Int'l CoaguChek XS Plus Japan CoaguChek Pro II WLAN CoaguChek Pro II
  • Manufacturer
    Roche

Manufacturer

Roche