Events

Alerte De Sécurité sur Trade Name: ADVIA Hematology System; 10345161959; Risk class I; Affected Model - ADVIA 560 Hematology System; Number of series affected: S020202, S020201, S020200, S020197.

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
    1867
  • Date
    2016-04-04
  • 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 has identified that equipment with software version 1.4.2133 does not indicate the following flags: warning flag for low sample volumes (flag w) and morphology flags indicating the presence of immature granulocytes (g) and atypical lymphocytes (l). if the user uses the device with the affected software version, the results may be lower than expected.
  • Action
    Action code HI 16-01. Initiated by Siemens, it is sent a Letter to the Customer prepared in March 2016 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: To ensure that the patient sample quantity is sufficient to perform the assay, it is recommended to follow the requirements described in the ADVIA 560 Hematology System Operator's Manual. Siemens recommends a review of the abnormal results for white cells , confirming them with the manual differential when necessary.

Device

Trade Name: ADVIA Hematology System; 10345161959; Risk class I; Affected Model - ADVIA 560 Hemato...

Manufacturer

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