Events

Avis De Sécurité sur Tina-quant Roche/Hitachi, cobas c111

Selon ALIMS (Agencija za lekove i medicinska sredstva), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Serbia qui a été fabriqué par Roche Diagnostics GmbH.

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
  • Date
    2015-04-20
  • Date de publication de l'événement
    2015-06-29
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    https://www.alims.gov.rs/latin/2015/06/29/vazno-obavestenje-o-medicinskom-sredstvu-d-di2-tina-quant-rochehitachi-i-d-di2-cobas-c111/
  • Notes / Alertes
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Notes supplémentaires dans les données
  • Cause
    Roche received a report of a patient case related to different results with coasys plus c and stago d-dimer for d-dimer gen. 2 test ". there was an overestimation of the measured value of the sample on the coasys plus c system, which led to false positives for the d-dimer. this problem is sample specific. immunoglobulins ("igm") interfere with "d-dimer gen. 2 "reagent, resulting in false elevated d-dimer results. the presence of immunoglobulins was demonstrated by immuno-adsorption chromatography, which showed that falsely elevated results were eliminated when immunoglobulins were removed from the sample in this way.

Device

Tina-quant Roche/Hitachi, cobas c111

Manufacturer

Roche Diagnostics GmbH