Events

Anvisa Registry: 80146501315 ///////////////////////////////////////////// ///////////////////////////////////////////////. Product / Lot / Validity. OPTIUM TIRAS TEST 10UN / 45001A233 / 30.06.2011 /. OPTIUM TIRAS TEST 25UN / 45001A285 / 31.07.2011 /. OPTIUM TIRAS TEST 50UN / 45001A247 / 31.07.2011 /. OPTIUM STRIPS GLICOSE BLOOD OTC 10UN / 45001A790 / 30.11.2011 /. OPTIUM STRIPS GLICOSE BLOOD OTC 10UN / 45001A852 / 31.12.2011. OPTIUM STRIPS GLICOSE BLOOD OTC 25UN / 45001A641 / 31.10.2011 / OPTIUM STRIPS GLICOSE BLOOD OTC 25UN / 45001A921 / 31.12.2011 /. OPTIUM STRIPS GLICOSE BLOOD OTC 50UN / 45001A665 / 31.10.2011 /. OPTIUM STRIPS GLICOSE BLOOD OTC 50UN / 45001A771 / 30.11.2011. 80146501661. OPTIUM XCEED TIRAS POC - 50UN / 45964 / 31.10.2011 / 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 ABBOTT LABORATÓRIOS DO BRASIL LTDA. 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
    1042
  • 날짜
    2010-12-22
  • 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
    Abbott indicates that strips exposed to temperatures between 22 ° C and 30 ° C and / or extended storage times may be more susceptible to false result. It is possible to point out that up to the present time Abbott Diabetes Care Brazil had no reported complaints about falsely low blood glucose results, based on the reason for the American recall. Blood glucose monitors have not been affected and your users can continue to use their glucose meter normally. ANVISA follows this case. ###### SEE UPDATE ON ALERT 1044. #######
  • 원인
    Affected test strips may provide falsely low blood glucose results, which may lead users to attempt to correct blood glucose unnecessarily and raise blood glucose levels due to a falsely low reading. the problem seems to be related to the application of the drop of blood in the test strip, requesting that it reapply blood more times than expected. this may occur regardless of the validity of the test strips, and / or if the test strips were stored at (or exposed to) high temperatures above 22 ° c and not exceed 30 ° c for an extended period of time.
  • 조치
    Customers who hold test strips for affected lots should not continue to use the product. Abbott Diabetes Care will replace these affected test strips at no cost. Abbott Diabetes Care of the United States initiated this recall following an internal routine quality analysis which indicated that blood glucose test strips from certain batches of Precision Xtra, Precision Xceed Pro, MediSense Optium, OptiumEZ and ReliOn Ultima products may require reapplication more than expected, which can cause false readings of blood glucose. PLEASE OBSERVE THE APPEARANCE CAREFULLY IN ANNEX.

Device

Anvisa Registry: 80146501315 ///////////////////////////////////////////// //////////////////////...

Manufacturer

ABBOTT LABORATÓRIOS DO BRASIL LTDA.
  • 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
    ANVSANVISA