Events

Freestyle Optium Neo Blood Glucose and Ketone 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
    2015-08-24
  • 사례 출판 날짜
    2015-08-24
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150824.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: freestyle optium neo blood glucose and ketone monitoring system it has come to our attention that medical device manufacturer, abbott diabetes care, has issued a field safety notice concerning a glucose and ketone monitoring system - freestyle optium neo blood glucose and ketone monitoring system. the manufacturer has become aware that a basal insulin titration feature of the affected product, which provides users with a long acting insulin dose suggestion, may in error recommend “0” units of insulin to be taken. this issue is encountered when the feature has been activated by healthcare professional (hcp), while the patient is in glycaemic control and their average fasting blood glucose level is within the target range that the hcp has set. the meter should suggest the basal dose that the patient took the prior day, but instead is incorrectly recommending “0” units. therefore, the manufacturer advises the users not to use this affected feature, if activated. according to the manufacturer, the issue would not pose a significant risk to user’s health or safety. the users may continue to test their blood glucose and/or ketones as this issue does not impact blood glucose and/or ketone results received from the meter. as a permanent solution, the manufacturer will update the firmware of the product. according to the local supplier, the affected product is distributed in hong kong; nonetheless, only those units with activated basal insulin titration feature would be involved. if you are in possession of the affected products and currently using the long acting suggestion, please contact your supplier and hcp for necessary actions. posted on 24 august 2015.

Device

Freestyle Optium Neo Blood Glucose and Ketone Monitoring System
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Freestyle Optium Neo Blood Glucose and Ketone 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