Events

Alerte De Sécurité sur Trade name: CAL IRI CALIBRATOR ADVIA CENTAUR ACS 180 SYSTEMS; ADVIA CENTAUR IRI Technical name: CAL IRI CALIBRATOR ADVIA CENTAUR ACS 180 SYSTEMS; ADVIA CENTAUR IRI ANVISA registration number: 10345160303; 10345161868 Affected Model: MAMMOMAT Inspiration

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; Siemens Healthcare Diagnostics Inc.

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
    2281
  • Date
    2017-04-28
  • 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
    Siemens does not recommend a review of previously generated results. ### UPDATED ON 10/26/2017, the company presented the completion report of the field action proving the sending of the security warning to the client with evidence of science and all actions completed.
  • Cause
    Siemens healthcare diagnostics is making this notice available to communicate the restoration of the insulin (iri) trial advia centaur systems to the world health organization (who) 1st irp standard 66/304. siemens internal investigation has identified that the current batches of insulin systems advia centaur recover approximately 40% higher than the first world health organization (who) irp 66/304 standardization based on slope values. the slope value was observed at 1.40 on advia centaur xp and 1.42 on advia centaur cp. siemens confirmed that assay reportable range, reference range, precision, analytical sensitivity, accuracy, pro-zone effect and linearity were not impacted by this problem and continue to achieve the performance characteristics mentioned in the instruction of use (ifu). the investigations also concluded that the root cause of this problem is related to the raw material used during the production of the iri calibrators. this problem has been corrected and the standardization to the 1st irp 66/304 who has been restored starting with the iri advia centaur primer packs finished in 201 when paired with batches of iri caliper finished in 02, which will be available in may 2017.
  • Action
    Field Action Code CC 17-10 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will notify the client.

Device

Trade name: CAL IRI CALIBRATOR ADVIA CENTAUR ACS 180 SYSTEMS; ADVIA CENTAUR IRI Technical name: C...

Manufacturer

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