Events

Registration Anvisa / product / lot and validity. 80146501315. 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
    1044
  • 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
    Please be aware that not all the test strips of the lots mentioned above have a filling time higher than expected. The blood glucose monitors used with these test strips are not affected. UPDATE OF INFORMATION: On January 6, 2011, the TechnoVigilance Unit held a meeting with Abbott Company where it provided further clarification on the deviation and the strategy of action that would be developed in Brazil, as well as in other countries that received the strips -test and that do not fit in the situations of risk observed in the analysis of the Company (time of exposure to high temperatures and term of validity of the product)
  • 원인
    Abbott diabetes care has identified, during routine quality assurance monitoring, that lots of optium blood glucose test strips have shown longer than expected filling time. this fact may be dependent on the age of the strips and the storage (or exposure) at high temperatures (30 ° c) for a long period of time. when this occurs (ie the fill time is greater than five (5) seconds, as indicated in the test strips and attached video instruction), a false low reading may occur.
  • 조치
    The Abbott Diabetes Care risk assessment process evaluated the problem as being of Low Risk, in general, for patients. The risk assessment included data based on Mean Kinetic Temperature (MCT) and expiration date for Abbott products in the different regions. The analysis showed that the performance of these strips does not differ from the other strips under use under normal conditions. This indicates that the situation of filling time above that expected only occurs in the worst cases of continuous storage conditions, for extended periods of time. Customers with test strips that did not demonstrate a longer than expected period of filling may continue to use these strips. Customers who have test strips from the aforementioned lots and evidence the fill time above the expected time on their strips should contact the Abbott Call Center 0800 703 0128 and the affected box will be exchanged free of charge.

Device

Registration Anvisa / product / lot and validity. 80146501315. OPTIUM TIRAS TEST 10UN / 45001A233...

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