Events

Alerte De Sécurité sur ADVIA CHEMISTRY XPT 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 Siemens Healthcare Diagnostics Inc. || Jeol Ltd..

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
    I1511-516
  • Numéro de l'événement
    2015DM-0013005
  • Date
    2015-11-06
  • 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=167
  • 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 affirms that it has identified several faults that may affect the workflow, among which are the reestablishment of the printing control, automatic archiving and erasing failed, restart of workstations, failure to communicate with the laboratory information system (lis) and re-establishment of calibration intervals, leading to the potential occurrence of incorrect calculations and adverse events due to poor sample treatment.

Device

ADVIA CHEMISTRY XPT SYSTEM
  • Modèle / numéro de série
    ADVIA CHEMISTRY XPT SYSTEM with software version 1.0.3
  • Description du dispositif
    The ADVIA CHEMISTRY XPT SYSTEM instrument is an automated analyzer for clinical chemistry or blood chemistry tests that processes tests in serum, plasma, urine or cerebrospinal fluid in random access mode and by series with a production rate of 1800 pho- totometric tests per hour and 600 tests of electrolytes (ISE) by now. Performs colorimetry, enzymatic, puntofinal, kinetic, selective ion for electrolytes. Of continuous random access. Uses urine, serum or plasma samples for in vitro diagnostic tests (IVD) of enzymes, biochemistry, cardiovascular, oncology, anemia, electrolytes, etc. It is in automated system that reports the values of the tests and communicates the results of clinical of the patient.
  • Manufacturer
    Siemens Healthcare Diagnostics Inc. || Jeol Ltd.

Manufacturer

Siemens Healthcare Diagnostics Inc. || Jeol Ltd.
  • Source
    NIDFSINVIMA