Events

Alerte De Sécurité sur Trade name: ADVIA Chemistry Triglicerides Concentrate TRIG_c Technical name: PROGESTERONE Registration number ANVISA: 10345160327; 10345161844; 10345160654 Hazard Class: II Affected Model: 50 determinations; 250 determinations; kit for 100 tests; kit for 200 tests; kit for 600 tests. Affected lot / series numbers: 0

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 Siemens Healthcare Diagnósticos S.A; 1) Siemens Healthcare Diagnostics Inc. 2) Siemens Healthcare Diagnostics Products Ltd..

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
    2100
  • Date
    2017-01-19
  • 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
    These trials should not be used to report results to patients who are using DHEA supplements. For patients using DHEA supplements, an alternative method should be used to measure Progesterone concentrations, such as Liquid Chromatography - Mass Spectroscopy (LCMS), which is not expected to demonstrate cross-reaction with DHEA-S. However, Siemens Progesterone assays can continue to be used to report results from patients not using DHEA supplements.
  • Cause
    Siemens healthcare diagnostics has confirmed that the presence of dhea-s (a dhea metabolite, a steroid hormone that is used as part of in vitro fertilization (ivf) protocols to increase the ovarian response and in treatment results) causes falsely elevated results for the progesterone trials listed in the "product data" annex, close to the clinically important decision level of progesterone.
  • Action
    Field Action Code CC 17-06 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send letter to the client.

Device

Trade name: ADVIA Chemistry Triglicerides Concentrate TRIG_c Technical name: PROGESTERONE Registr...

Manufacturer

Siemens Healthcare Diagnósticos S.A; 1) Siemens Healthcare Diagnostics Inc. 2) Siemens Healthcare...
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA