Events

Alerte De Sécurité sur Sirolimus Flex® - Dimension. ANVISA Registry No. 10345161657. Risk class III. Lot: EB6064. Distributed as follows in Brazil: 17 in São José dos Pinhais-PR; 16 in Rio de Janeiro-RJ; 3 in Campinas-SP; 2 in Recife-PE.

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
    1838
  • Date
    2016-03-10
  • 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
  • Cause
    Siemens healthcare comes through letter dc 16-01 to alert its customers in brazil about the siro reagent, lot eb6064 that does not meet the stability of open bottle of 2 days. internal tests showed a bias (bias) ranging from -82% to + 123% in a pool sample with a concentration of sirolimus of 8.7 ng / ml [9.5 mmol / l] when tested on subsequent days after well within two days. shortly after opening, the results are not affected at the beginning of the stability period.
  • Action
    The field action code 16-01 initiated by Siemens addresses the sending of a Letter to the Customer with risk classification III (situation in which there is a low probability that the use or exposure to a health product may cause adverse health consequences) . Recommendation to Users and Patients: Siemens recommends discontinuing use and disposing of the Sirolimus reagent stock from lot EB6064. In addition, it is recommended that the laboratory conduct a retrospective analysis of the results of Sirolimus samples generated using the EB6064 reagent batch. However, it is worth noting that the sample collection and handling section contained in the Sirolimus reagent's instructions for sample stability is consulted in order to decide whether these samples can be retested using an alternative batch of reagent.

Device

Sirolimus Flex® - Dimension. ANVISA Registry No. 10345161657. Risk class III. Lot: EB6064. Distri...

Manufacturer

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