Events

Safety Alert for 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 /

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by ABBOTT LABORATÓRIOS DO BRASIL LTDA..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1042
  • Date
    2010-12-22
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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. #######
  • Reason
    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.
  • Action
    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.
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “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