LifeScan OneTouch Ultra blood glucose meters 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Johnson & Johnson 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
    2006-12-19
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 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
    Dh closely monitoring safety of lifescan blood glucose meter the department of health (dh) was notified by johnson & johnson (hong kong) limited that the company was following up whether the lifescan onetouch ultra blood glucose meters supplied to hong kong were of the same design and software as those available in united kingdom. a dh spokesman said that the unit of measurement of some meters of this model in united kingdom might change from mmol/l to mg/dl if the meter was dropped or if the battery was changed when the meter was switched on. the spokesman said, "as a precautionary measure, users of any brands of blood glucose meters should always check and ensure that the unit of measurement is in mmol/l in every test. if the unit of measurement is in mg/dl, they should immediately contact their suppliers." "members of the public are advised to follow strictly instructions in the manual when using blood glucose meters." the spokesman said that dh had informed the public and private hospitals, nursing homes, medical professional associations, and diabetes patient support groups about this safety issue. dh has not received any report of adverse events related to the unit of measurement issue, he added. relevant information has also been posted on the mdco website http://www.Mdco.Gov.Hk/english/recalls/recalls.Html . ends/tuesday, december 19, 2006 nnnn.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Press release: DH Closely Monitoring Safety of Lifescan Blood Glucose Meter
  • Manufacturer

Manufacturer