Events

Alerte De Sécurité sur MEDISENSE OPTIUM GLUCOSE STRIP TRUE MEASURE - Test Strips 10 Units Registration ANVISA nº10055311118

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par ABBOTT LABORATORIOS DO BRASIL LTDA.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    813
  • Date
    2005-08-10
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    This exchange, which signifies a disagreement with the date printed in the original box, occurred only in the first stage of adequacy, therefore both boxes with the correct validity and the incorrect validity were distributed on the market. The company Abbott Laboratories of Brazil, Diabetes Care Division, further clarifies that the Test Strips 10 Medisense Optium units are packaged individually, and in each strip there is printed information of the lot and the expiration date, which becomes visible at the correct date each use of the Test Strips. You still understand that this product will hardly be used after the correct expiration date (28/0212006), as it contains only 10 units. ANVISA will be accompanying the actions that will be carried out by the company.
  • Cause
    The product medisense optium - test strips with 10 units, lot 10422 with validity to 02/28/06, at the moment of adaptation, that is, in the labeling (which is done only to include the legal words - dealer's data in brazil, registration number, etc ...) there was an exchange of the product's expiration date. correct validity date: 02/28/06 - printed in the original box incorrect validity date: 06/28/06 - on the portuguese label.
  • Action
    The company issued a letter to its customers and is awaiting contact to know the impact of this occurrence on the stock and to meet the need to correct this operational failure. The company makes itself available for any clarification necessary through the Customer Service Center 0800 7030128 of Monday on Friday from 08:00 to 18:00 hours.

Device

MEDISENSE OPTIUM GLUCOSE STRIP TRUE MEASURE - Test Strips 10 Units Registration ANVISA nº10055311118

Manufacturer

ABBOTT LABORATORIOS DO BRASIL LTDA
  • Source
    ANVSANVISA