Events

SureStep blood glucose monitoring systems. Catalog No. 010-341; Series No.s .: L6000 XX XXXXX to L7205 XX XXXXX, L7206 GA 00001 to L7206 GA 01128 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 LifeScan Inc A Jonhson 60 Jonhson Co 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
  • 사례 ID
    235
  • 날짜
    2000-12-15
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • 데이터 추가 비고
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • 원인
    Removal of the monitors mentioned because of a message error1 that appears in place of a reading saying "high" when a patient's blood glucose was> = 500mg / dl. on friday, december 15, 2000, lifescan pleaded guilty to the indictment in federal court for improper identification of a medical device, refusing to provide proper fda notification, and reporting false and misleading fda findings to the fda. connection with the investigation of the mentioned problems with the surecan monitor. the author states that lifescan knew about the two defects in the monitors and did not disclose the problems to customers and the fda. lifescan was forced to pay $ 60 million in fines. jonhson & jonhson stated that no lifescan employee was involved in a deliberate wrongdoing, however, they admitted that the product label was defective and that the company did not notify the fda and was very slow in providing a solution to the problem. the author reports that the guilty plea has also determined a civil claim settlement where the us government received $ 30.6 million in restitution of medical care funds used to purchase surescan monitors. another class action lawsuit filed on behalf of users of surescan monitors is still pending.
  • 조치
    Make sure that you have been contacted by LifeScan. Lifescan states that the problems were corrected in 1997 and 1998, with the affected meters having been replaced, free of charge, by the company. ECRI states that it currently classifies SureStep's glucose monitor as an acceptable device and has no evidence to suggest that this rating should be changed. If you are using a Sure Step glucose monitor and have questions, please contact your local representative or directly with LifeScan at 1 (408) 946-6070 in the USA. If you observe any measurement that is incorrect or inconsistent with the clinic, notify the event to ANVISA's Tecnovigilância by e-mail tecnovigilância@anvisa.gov.br or by telephone / fax 0xx-61-448-1257.

Device

SureStep blood glucose monitoring systems. Catalog No. 010-341; Series No.s .: L6000 XX XXXXX to ...

Manufacturer

LifeScan Inc A Jonhson 60 Jonhson Co
  • Source
    ANVSANVISA