Events

Avis De Sécurité sur RPD / ClinChem fully automated

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 Roche.

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
    2015-03-10
  • 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
    Customers complained about a 20% decrease in control levels when using non-roche controls (e.G. thermofisher liqimmune) with homocysteine reagent lot 697811 on cobas c 501. after changing to lot 604303, the controls were within range. the comparison of patient samples with reagent lot 697811 vs 604303 showed a bias of up to 54%. edta plasma samples were used. this negative bias could, in the worst case, lead to inaccurately low homocysteine results. however, it is unlikely that inaccurately low homocysteine results would lead to an immediate adverse event, since it has been demonstrated that homocysteine is a predictor of long-term (late cardiac events), rather than short-term cardiovascular risk. .

Device

RPD / ClinChem fully automated
  • Modèle / numéro de série
    05 385 415 190 Lot No.: 69781101 06 542 921 190 Lot No.: 69781401 05 385 377 190 Lot No.: 69780301
  • Manufacturer
    Roche

Manufacturer

Roche