Events

Alerte De Sécurité sur Product trade name: VANC2 ONLINE TDM VANCOMYCIN /// Record number: 10287410652 /// Lots affected: 60199901; 60229601; 60434301; 61143301; 61187701; 61647301; 61651201; 61854401; 61955901; 67419801; 68812701; 69069401; 69428701; 69737001; 13312901./// Hazard class of the product: II.

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
    1923
  • Date
    2016-06-29
  • 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
    If in doubt, contact the record holder of the company. #### 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
    The registrant forwarded to anvisa the following description: "roche diagnostics gmbh, the legal manufacturer of the product involved in this notification, has identified that the instructions for use for vancomycin used in the cobas c 311/501/502 and modular analytics p present an incorrect method comparison with the cobas integra® 800 analyzer. it should be noted that although the comparison was made with cobas integra® 800, this comparison is also applicable to cobas integra® 400 ". the reagent in cobas integra is not yet harmonized, results generated with cobas integra can be up to 20% higher than those generated with the cobas c or modular analytics p-module analyzers. the comparison of method presented in the use instruction can lead to the assumption that both methods are comparable and may affect the interpretation of vancomycin test results./// possible consequences of using the product: comparison of methods (cobas integra and cobas / hitachi) presented in the current use instruction may potentially cause error in the interpretation of the vancomycin concentration. the difference between the dosages can be interpreted as a decrease in vancomycin concentration, which may lead to increased dosage. in this case, a medical risk of toxic effects due to increased vancomycin dosage can not be excluded.
  • Action
    Classification of risk: III /// Classification of the field action: Update, correction or complementation of the instructions for use./// Field action code: SBN_CPS_2016_010 /// Recommendations to users and patients: disregard the comparison of incorrect method in the Vancomycin Current Directions for Use. The corrected use instruction will be available in the third quarter of 2016.

Device

Product trade name: VANC2 ONLINE TDM VANCOMYCIN /// Record number: 10287410652 /// Lots affected:...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH.