Events

CONTOUR® DIABETES App 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 Ascensia Diabetes Care 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
  • 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
    We would like to inform you about a potential issue we have identified with the contour® diabetes app (version 1.2.0 or lower) when it is synchronizing data with the contour cloud. there is the potential for an isolated, very rare situation to occur where some of the data stored in the contour cloud may be incomplete. please note that this situation will only affect users using the same contour cloud account for the app on more than one mobile device (smartphone or tablet). the data on the contour® next/plus one meter and on the mobile device (“primary device”) that directly receives data from the meter are not affected, and will always show the correct and complete information including glucose values and meal markers. a health care professional report can still be generated and transmitted from the primary device (phone or tablet). if you have used the contour® diabetes app prior to version 1.2.0 in switzerland or poland this may be the second letter that you have received regarding this issue. version 1.2.0 did not completely resolve the issue. .

Device

CONTOUR® DIABETES App

Manufacturer

Ascensia Diabetes Care