Events

Alerte De Sécurité sur LIVES EBV VCA - EA IgG - Record 10158120637 - Lots 1000945440 and 1001073190.

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 bioMérieux Brasil S.A..

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
    1152
  • Date
    2012-07-23
  • 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 an untreated SPR is used with the C1 (positive control) or S1 (kit standard) the customer will verify a control or calibration of the kit, not compliant, in this case there will be no result provided to the patients. If an untreated SPR is used with C2 (negative control), this negative control will give a negative result as expected, and the client will not be aware of this problem. If an untreated SPR (cone) is used with a sample, based on the fact that the signal loss may be 50%, the following situations may occur: - a sample with a theoretical positive result could give a wrong result but not a negative result and a sample with erroneous theoretical feedback could give a negative result. Applying the Risk Assessment procedure from our employer we arrive at: The severity of providing a false report is SERIOUS, and may have a negative influence on the medical diagnosis without permanent impact on the patient's health because other diagnostic information must be available. More specifically, because the biological interpretation for a diagnosis of infectious mononucleosis should be based on the results of at least 03 EBV VIDAS assays and not only the results of VIDAS EBV VCA / EA IgG. The probability of occurrence is PROBABLE, indicating that it could occur at multiple times (more often) over the lifetime of the affected lots. In general, the risk associated with the presence of untreated SPRs in both batches of VIDAS EBV VCA / EA IgG is considered to be GREATER. #### CLOSED ####
  • Cause
    Investigations carried out by the quality area identified that some sprs (cones) included in the kits of these two lots did not receive the appropriate treatment and were also not irradiated. this event induces the loss of sensitivity and consequently possibility of false negative results.
  • Action
    The biological interpretation for the diagnosis of mononucleosis should be based on at least the results of 03 trials with VIDAS EBV (VIDAS EBVEBNA IgG, VIDAS EBV VCA / EA IgG and VIDAS EBV VCA IgM ). In the presence of negative results for the 03 VIDAS markers and a suspected mononucleosis, collect a second sample one to two weeks later and test the two collections in parallel. Retest the patients for whom the negative interpretation of the diagnosis of Infectious Mononucleosis was given based on the results of the 03 EBV LIVES quoted in the package insert, when in use the two committed lots. Return bioMérieux Brasil on the quantity of kits of these batches still in stock, for their replacement, through the Department of Customer Service, Use the spreadsheet elaborated by biomérieux to monitor the re-tests and return it to the completed Customer Service.

Device

LIVES EBV VCA - EA IgG - Record 10158120637 - Lots 1000945440 and 1001073190.

Manufacturer

bioMérieux Brasil S.A.