Events

accu-chek flexlink plus infusion sets 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Roche Diagnostics 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
    2011-03-02
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20110302.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
    Press release
  • 원인
    Safety alert on accu-chek flexlink plus infusion sets the department of health (dh) today (march 2) warned the public not to use accu-chek flexlink plus infusion sets, manufactured by roche diagnostics (roche), because of the potential for under delivery of insulin due to a kinked cannula when inserting the infusion set. the dh, through its routine surveillance of medical devices, noticed that roche has announced a recall of the above product. roche's investigation into complaints regarding kinked cannulas revealed that in some cases the distance between the needle cut and the end of the soft cannula is too small and may contribute to an impaired cannula. the malfunction of infusion sets may result in under delivery of insulin leading to elevation of blood glucose levels, or hyperglycemia. symptoms of hyperglycemia include nausea/vomiting, blurred vision, excessive thirst or hunger, frequent urination, fatigue and headache. a dh spokesman remarked that hyperglycemia is a significant health risk, as untreated hyperglycemia may lead to death in serious cases. although preliminary investigation has revealed that there is neither record of marketing of the product nor report of such adverse events in hong kong, the potentially serious consequences and the fact that there may be occasional patients here who have somehow obtained the devices overseas justify a public alert. roche diagnostics (hong kong) ltd has set up a hotline, 2485 7512, to answer public enquiries from 9am to 12 noon, and from 2pm to 5pm between monday and friday. meanwhile, dh has informed all public and private hospitals and medical professional associations about the matter and advised them to remain vigilant. the spokesman said: "dh will closely monitor developments. members of the public should consult their healthcare professionals for advice if in doubt or feel unwell." ends/wednesday, march 2, 2011 issued at hkt 16:35.

Device

accu-chek flexlink plus infusion sets

Manufacturer

Roche Diagnostics