Events

Avis De Sécurité sur ADVIA® 560 Hematology System

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Siemens Healthcare Diagnostics Inc..

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Siemens healthcare diagnostics is conducting an urgent field safety notice for the advia 560 hematology system software. siemens is investigating an issue which may cause an incorrect result to be reported. siemens has received two reports of multiple discordant records for the same sample id in the advia 560 hematology system database that occurred during the installation of the systems. the database should only contain one record of a sample id number for any given time and date. if there are multiple records for the same sample id, it is possible that multiple results may be manually or automatically sent to the laboratory information system (lis), printed or displayed on the results report screen. .

Device

ADVIA® 560 Hematology System

Manufacturer

Siemens Healthcare Diagnostics Inc.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    AMPMDRS