Events

Alerte De Sécurité sur VITEK 2 AST-YS 07. ANVISA Registration No. 10158120592.

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 Biomerieux Inc..

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
    1552
  • Date
    2015-04-22
  • 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
    According to the risk assessment carried out by the company, the SEVERITY of the potential consequences for patients of incorrect or delayed results may be considered CRITICAL, which may lead to permanent deterioration, high impact on the patient's health or even death . The probability of occurrence was determined by the company as OCASIONAL, which means "possible to occur a few times during the product life cycle." The general risk posed by the company is MODERATED in a general way. relevant in Brazil since Flucitosycin is not used as therapy in case of fungemia (as it appears in the technical literature available in the market).
  • Cause
    During the quality control tests to be performed by the clients, it was identified that strain atcc 6258 - candida krusei, naturally resistant to the antibiotic flucitosina, presented results outside the minimum range required for such antibiotic, which means a sensitive result for flucitosina.
  • Action
    The company has already started communicating with its customers, alerting to the problem in question and is developing a new formulation for the product, which should be available within 6 months. Identify if you have products at risk in stock and carefully read the letter disclosed by the company, to take the necessary steps - letter available at http://portal.anvisa.gov.br/wps/wcm/connect/bae52680481c317688dfadbdc15bfe28/Notifica%C3 A + A + + + + + + + + + + + + + + + + + + + + + + + A9rieux.pdf • MOD = AJPERES)

Device

VITEK 2 AST-YS 07. ANVISA Registration No. 10158120592.

Manufacturer

Biomerieux Inc.