Events

Alerte De Sécurité sur REVISION DATE OF REVISION DIMENSION® Technical Name: REVISED IRRIGATION REAGENT - DIMENSION® ANVISA Registration Number: 10345161043 Hazard Class: II Affected Model: Affected Lot / Series Numbers: BA7006, BA7116, BB7006, DB6267, FD6309 , GB7060

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 Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics 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
    2095
  • Date
    2016-09-30
  • 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
    If users receive any complaints of illness or adverse events associated with the product, they should immediately contact the Siemens Customer Support Center or the Siemens technical support representative in their locality.
  • Cause
    Iron dimension and dimension wear a concentration other than that listed in the instructions for use. deferoxamine is cited in the directions for use dimension and dimension vista as a non-interfering substance. the concentration that was used for interference tests (250 ng / dl or 3.8 nmol / l) is significantly lower than expected in clinical practice. siemens healthcare diagnostics sa is providing an update in the section limitations of the instructions for use procedure, iron test for dimension and dimension vista systems, indicating that: patients treated with drugs that bind to metals (eg deferoxamine) may present a reduction in values iron, since the chelating iron may not react adequately in this test. the reference to deferoxamine at a concentration of 250 ng / dl (3.8 nmol / l) will be removed from the section "non-interfering substances" in the instructions for use. the information provided in this release, related to deferoxamine, replaces the information contained on this substance in the current ferro operating instructions for the dimension and dimension vista systems until their respective operating instructions are updated.
  • Action
    Field Action Code VC 16-07 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send Letter to the Client.

Device

REVISION DATE OF REVISION DIMENSION® Technical Name: REVISED IRRIGATION REAGENT - DIMENSION® ANVI...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Inc.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA