Events

Alerte De Sécurité sur Trade name: GENT2 ONLINE TDM GENTAMICIN (Products for in vitro diagnostic use) /// register 10287410655 /// risk class II (Products presenting medium risk to user or patient and low risk to public health) // Lot 11916601 (distributed 2 in São Paulo-SP and 1 in Porto Velho-RO).

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Roche Diagnóstica Brasil Ltda; 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
    1909
  • Date
    2016-06-13
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    For questions and support, please contact the CEAC Service Center - 08007720295 of Roche Diagnóstica Brasil Ltda. #### Update of the field action: UPDATED ON 10/27/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Cause
    Roche diagnostics gmbh, the legal manufacturer of the product involved in this notification, after internal investigations, has identified an increase in patient specimen recovery of approximately 15-20% when using the online tdm gentamicin test with the recent batches of the preciset tdm calibrator i 615118, 619681, 126387, 140735. tdm controls and external quality assessment also showed a recovery recovery of approximately 15%. except for combination with tdm control series lot 125783, in which this effect was not presented. these observations were confirmed for the online tdm gentamicin reagent kits for use in cobas ce analyzers modular analytics

    . faced with this question, a possible achievement of falsely elevated gentamicin levels may lead to incorrect reduction of drug dosage. too much dosage reduction may result, given the worst case scenario, in subtherapeutic levels of gentamicin. gentamicin is also used for the treatment of contagious infections, therefore, very low serum levels of this drug may also lead to the spread of the infection.

  • Action
    Action code SBN_CPS_2016_009. Letter to customers with recommendations to Stop using GENT2 temporarily until a valid Reagent / Calibrator / Control combination is available.

Device

Trade name: GENT2 ONLINE TDM GENTAMICIN (Products for in vitro diagnostic use) /// register 10287...

Manufacturer

Roche Diagnóstica Brasil Ltda; Roche Diagnostics GmBH