Alerte De Sécurité sur Trade name: Xpert EV. Technical Name: Enterovirus. ANVISA registration number: 81062710013. Risk class: II. Affected model: Kit with 10 tests (cartridges with integrated reaction tubes). Affected serial numbers: 1000045409 / cartridge batch 06802

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 CEPHEID BRASIL IMPORTAÇÃO, EXPORTAÇÃO E COMÉRCIO DE PRODUTOS DE DIGANÓSTICOS LTDA.; CEPHEID.

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
    2391
  • Date
    2017-10-11
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • 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
    The proposed action to address device failures is to send customers a Field Security Notification, which informs customers to stop using the Xpert EV product, lot 1000045409/06802, which will later be collected by the company. According to the Instructions for Use, users should repeat the test with an extra specimen. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Complementary Information: - Date of identification of the problem by the company: 09/26/2017 - Date of notification notice to Anvisa: 10/11/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Cause
    There has been a high invalid result rate and low probe verification failures (e5007) by customers when using xpert ev lot 1000045409/06802. field data from customers who were receiving invalid errors were evaluated. the invalid error rate was considered to be 13% (228 total tests). additionally during data analysis, a failure rate of 15% of e5007 faults was found. - internal test of this lot resulted in 4 error of detection of loss of signal (sld) of 210 cartridges tested. the lot was manufactured with an open cartridge lot which showed a change from the initial valve value of the cartridge integrity test of the valve body compared to other batches manufactured in the same period. the change found indicated that the valve bodies used to manufacture the open cartridge batch potentially exhibited weak retention of the valve body pressure.
  • Action
    Field Action CPHD-003/2017 Code triggered under the responsibility of the company Cepheid Brazil Import, Export and Trade of Products of Diganósticos Ltda. It will make recollection.