Events

blood glucose monitoring systems 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Abbott Diabetes Care 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
    2014-03-03
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140303.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
    Recall of certain brands of abbott diabetes care blood glucose monitoring systems the department of health (dh) today (february 28) drew public attention to the recall by abbott diabetes care of certain brands of its blood glucose monitoring systems which may produce inaccurate glucose results. the dh received the above safety alert from the local supplier, abbott laboratories limited. the manufacturer, abbott diabetes care, has identified through internal testing and investigation that certain brands of their blood glucose monitoring systems, namely freestyle, freestyle flash, freestyle papillon, freestyle mini, freestyle papillon mini, optium mini blood glucose meters, freestyle navigator continuous glucose monitoring system and freestyle blood glucose meter built into the omnipod insulin management system, have the potential to produce erroneously low blood glucose results when used in conjunction with any freestyle test strip. a spokesman for the dh explained that falsely low blood glucose readings may mislead a diabetic patient into inappropriate management of his or her condition, resulting in hyperglycemia. so far, the dh has not received any local report of adverse events arising from use of the affected products. people who are using the specific brands of glucose meters concerned should contact abbott laboratories limited for advice and follow-up," the spokesman added. the company has set up a customer service hotline 5808 4196 to answer related enquiries. ends/friday, february 28, 2014.

Device

blood glucose monitoring systems

Manufacturer

Abbott Diabetes Care
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DH