Events

Alerte De Sécurité sur ADVIA 560 and 360 HEMATOLOGY SYSTEM

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Diatron Mi Plc || 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
    I1604-176
  • Numéro de l'événement
    2015DM-0013266
  • Date
    2016-04-29
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=144
  • Notes / Alertes
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • Notes supplémentaires dans les données
  • Cause
    The manufacturer has identified that after its use erroneous results can be obtained, since they do not indicate the following flag: the warning flag for low sample volumes (w) and the flags of morphology that indicate the presence of immature granulocytes (g) and atypical lymphocytes (g) , which could lead to potentially adverse events on patients due to diagnostic errors.

Device

ADVIA 560 and 360 HEMATOLOGY SYSTEM
  • Modèle / numéro de série
    ADVIA 560, serial S020202, S020201, S020200 and S020197, with software version 4.1.2133
  • Description du dispositif
    The ADVIA 560 and 360 HEMATOLOGY SYSTEM are a fully automated, high-quality hematology system for use in in vitro diagnostics in clinical laboratories. The system uses the impedance method for the measurement of deleucocyte concentrations (WBC), erythrocytes (RBC) and platelets (PLT). The concentration of hemoglobin (HGB) of the red blood cells semide by photometric refraction. The system provides a differential measurement of the WBC 5-part leukocyte formula (LYM%, MON%, NEU%, EOS%, BAS%) by laser-based optical flow cytometry technology. The ADVIA 560 and the ADVIA 360 HEMATOLOGY SYSTEM identify patients with hematological parameters within and outside the established reference ranges. The system can process up to 100 ul of whole blood that is agicoagulated, automatically for hematology.
  • Manufacturer
    Diatron Mi Plc || Siemens Healthcare Diagnostics Inc

Manufacturer

Diatron Mi Plc || Siemens Healthcare Diagnostics Inc
  • Source
    NIDFSINVIMA