Events

Alerta De Seguridad para 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 /

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por ABBOTT LABORATÓRIOS DO BRASIL LTDA..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1044
  • Fecha
    2010-12-22
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    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)
  • Causa
    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.
  • Acción
    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.
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “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