Events

Accu-Chek Mobile System 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Roche 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
    2014-05-23
  • 사례 출판 날짜
    2014-05-23
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140523.html
  • 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: roche accu-chek mobile system medical device manufacturer, roche, has issued a field safety notice concerning accu-chek mobile system. the manufacturer is introducing enhanced instructions and training for the use of the accu-chek mobile system. the new and enhanced training materials will be included in the accu-chek mobile kits and will be distributed to current accu-chek mobile users. according to the manufacturer, the strip-free accu-chek mobile blood glucose monitoring system offers a unique testing procedure, which requires particular awareness of people with diabetes regarding its proper handling. the manufacturer has identified that a small number of people with diabetes using the affected device have experienced falsely elevated blood glucose readings when using the system as a result of not following the described and labelled handling instructions. such improper handling can include, for example, unclean hands contaminated with glucose-containing substances, pressing the finger too hard and too long on the test field or smearing the blood while performing a test. the manufacturer has decided to enhance its training and handling instructions for the accu-chek mobile system to increase their visibility in the meter kit to ensure people with diabetes’ understanding of how to appropriately use the system. this will enable the users to obtain safe and reliable blood glucose (bg) readings at all times. the manufacturer advises patients that they can continue to use their accu-chek mobile device safely and reliably by carefully following the instructions included in the new training leaflet. if patients have concerns about the accuracy of a bg reading, they should refer to the possible sources of error listed in the user manual and perform a test with a control solution or they should contact their healthcare provider and follow the individual advice. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 may 2014.

Device

Accu-Chek Mobile System
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Roche Accu-Chek Mobile System
  • Manufacturer
    Roche

Manufacturer

Roche