Events

Alerte De Sécurité sur CREA plus, CREP2, LACT2, Lactate, GLU, TRIGL / TG, TRIGGS, TRIG / GB, CHOL / CHOL2, HDL-C plus 3rd generation / HDLC3, LDL_C plus 2nd generation / LDL_C. UA2 / UA plus - See Annex I (products and records). Potential customers affected - Annex 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
    1612
  • Date
    2015-06-10
  • 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
    The manufacturer received a total of 6 complaints related to inadequately reduced test results based on Trinder's reaction to Acetaminophen and Metamizole. The frequency of occurrence is very remote, as the interference situation occurs only in certain rare circumstances, when there is insufficient waiting time between the administration of these drugs and collection of blood for the tests. The probability of occurrence of a Trinder test interference also depends on the frequency of use of the following medications: Paracetamol (acetaminophen), Metamizol (Novaminsulfone, dipyrone). Acetaminophen and Metamizole are two of the most commonly used analgesics. For both drugs relevant plasma concentrations leading to interferences are achieved directly following intravenous administration, during intravenous administration, or as a result of metabolic disturbances or drug abuse. Critical concentrations of acetaminophen occur due to accidental intoxication as well as intended to commit suicide.
  • Cause
    Roche diagnostics gmbh, the legal manufacturer of the products involved in this notification, is making changes to the interferon session of the reagent use instruction based on trinder reaction in order to warn of possible interference with the napqi metabolite of the drug acetaminophen, with the metamizole and with the acetaminophen antidote, nac. the trinder reaction is a colorimetric reaction between hydrogen peroxide, a phenolic derivative and aminoantipyrine catalyzed in the presence of peroxidase, and is the working mechanism of the tests involved in this release. roche diagnostica brasil has not been notified to date of any occurrence related to this interference in national territory.
  • Action
    The company recommends considering: • The recovery of Trinder's tests may be falsely low when the sample is collected while NAC, NAPQI and Metamizol levels are still present; • Venous puncture should be performed prior to administration of Metamizol. Venous puncture performed immediately after or during the administration of Metamizol may lead to falsely low results. See Annex III

Device

CREA plus, CREP2, LACT2, Lactate, GLU, TRIGL / TG, TRIGGS, TRIG / GB, CHOL / CHOL2, HDL-C plus 3r...

Manufacturer

Roche Diagnóstica Brasil Ltda.; Roche Diagnostics GmBH