Events

Alerte De Sécurité sur ADVIA CENTAUR, Registration no. 10345160020 - Serial numbers - Attachment -Carta to the Client.

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 Ltda.; 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
    1430
  • Date
    2014-09-26
  • 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 company informs that patient demographics (name, age, gender, ID) of an earlier sample are incorrectly transmitted to the LIS with the current patient sample results, the data also appears incorrectly in the worklist and printed reports . Patient outcomes are not affected if the ADVIA Centaur and ADVIA Centaur XP immunoassay systems use Sample ID (SID) as the primary identifier for all outcomes. A delay in reporting may occur. The overseas manufacturer performed the problem analysis, evaluating all the inherent risks that generated the corrective action in the field. Based on the investigation and mitigation of the risk conducted, this action was classified as without health risk, its severity being low and its probability of occurrence extremely unlikely.
  • Cause
    Siemens healthcare diagnostics has identified a problem with patient demographics sent to the lis of the advia centaur® / advia centaur® xp immunoassay systems. siemens has confirmed that under extremely rare circumstances the demographics of patients from a previous order received from the lis are merged with the next order. this problem may occur when the lis data buffer becomes full in the advia centaur system, and a particular character is encountered in the last five positions in the lis data buffer.
  • Action
    Siemens recommends following the instructions provided in the chart if the equipment in use is connected to a LIS system that transmits demographic patient data at each request. If the equipment is connected to a LIS system that does not transmit demographic patient data, no action is required. In addition, Siemens recommends retaining the letter with the laboratory records and forwarding the notification to anyone who may have access to the products.

Device

ADVIA CENTAUR, Registration no. 10345160020 - Serial numbers - Attachment -Carta to the Client.

Manufacturer

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