Events

FreeStyle Lite blood glucose test strips 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
    2013-11-26
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131126a.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
    Further recall of selected lots of freestyle lite blood glucose test strips the department of health (dh) today (november 26) drew public attention to abbott diabetes care's further recall of other selected lots of its freestyle lite blood glucose test strips due to the potential for giving erroneously low blood glucose results when used in conjunction with certain brands of blood glucose meters also manufactured by the company. further to the press release issued by the dh yesterday (november 25) on the recall of certain lots of freestyle and freestyle lite blood glucose test strips by abbott diabetes care, the department, through its routine surveillance on medical devices, noticed abbott diabetes care's recall notice posted by the united kingdom's medicines and healthcare products regulatory agency involving three other lots of freestyle lite blood glucose test strips (lot numbers: 1284962, 1366626 and 1372611). according to the notice, the three affected lots may produce erroneously low blood glucose results and out of range control solution results when used in conjunction with freestyle blood glucose meters, freestyle mini blood glucose meters, freestyle navigator and the freestyle meter built into the omnipodsystem. 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 hyperglycaemia. "preliminary enquiries with the local supplier, abbott laboratories limited, revealed no evidence of the affected products having been distributed in hong kong. the dh will continue to monitor the situation," the spokesman said. so far, the dh has not received any local reports of adverse events arising from use of the affected products. people who have the test strips belonging to the affected lots and are using the specific brands of glucose meters concerned should contact abbott laboratories limited for advice and follow-up," the spokesman stressed. the company has set up a customer service hotline, 5808 4196, to answer related enquiries. ends.

Device

FreeStyle Lite blood glucose test strips
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Press release: Further recall of selected lots of FreeStyle Lite blood glucose test strips
  • Manufacturer
    Abbott Diabetes Care

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