Events

Alerte De Sécurité sur Preanalytical Equipment for Sample Management - ROCHE

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 Roche Diagnostics GMBH.

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
    I1603-86
  • Numéro de l'événement
    2015DM-0013314
  • Date
    2016-02-25
  • 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=155
  • 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 reports that he was notified of a case in which the uncovered sample tubes are not placed correctly back in the rack tube transport (rtt), the open sample tubes were found in the decapper outsorter area, contaminating the equipment with blood , the material of the tubes was spilled and could not be used to carry out the analyzes, leading to potentially adverse events on the patients and reprocesses for the analysis of the samples.

Device

Preanalytical Equipment for Sample Management - ROCHE
  • Modèle / numéro de série
    p512, specific serials.
  • Description du dispositif
    The preanalytic system COBAS 8100 and models p512 and p612 is a modular equipment interconnected with each other, for the processing and transport of patient samples in the clinical laboratory. The system has been designed to centrifuge the samples of the patients, remove and insert the tampons, apply the barcode labels and prepare the aliquots with the pipette from the primary samples. You can sort the samples online or off and temporarily store the samples. The system transports the different individualized samples among the cobas analytical modules for immunology, blood chemistry, hematology, hormones, drugs, urine, coagulation and special for the respective laboratory analyzes. The system does not report sample results values, it is not a sample analyzer.
  • Manufacturer
    Roche Diagnostics GMBH

Manufacturer

Roche Diagnostics GMBH