Events

FreeStyle Libre Flash Glucose Monitoring System 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
    2014-10-14
  • 사례 출판 날짜
    2014-10-14
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141014a.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: abbott diabetes care freestyle libre flash glucose monitoring system the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice (fsn) concerning freestyle libre flash glucose monitoring system, manufactured by abbott diabetes care. according to the fsn, one of the safety features of the freestyle libre system is the software, which is designed to disable the sensor if it identifies a possible loss of sensor power. in rare cases this disabling feature may not function correctly, and there is the potential for power loss to occur which may not be properly identified by the system. in these instances, when a scan is completed the sensor may provide previously collected glucose values as if they are current results. if this occurs, the results produced from the scan and seen on the reader screen may be erroneous. however, the built-in blood glucose meter system is unaffected by this issue. the above issue can be easily identified as the user would see the same glucose result on the screen each time they scanned during a period of power loss. they may also notice a gap in results on the 8-hour graph on the reader screen. if any reading from a scan seems unexpected or does not seem to match the way users are feeling, users should use the meter and test strips to perform a blood glucose test to verify the results produced by a scan. if the problem continues, users should contact abbott diabetes care customer service. furthermore, the manufacturer has made a change to the software that has corrected this issue for all newly manufactured freestyle libre sensors. for details, please refer to mhra website : http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con462307 according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 october 2014.

Device

FreeStyle Libre Flash Glucose Monitoring System
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Abbott Diabetes Care FreeStyle Libre Flash Glucose Monitoring System
  • 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