Events

Safety Alert for 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 /

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
    1044
  • 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
    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)
  • Reason
    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.
  • Action
    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.
  • 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