Events

Alerte De Sécurité sur TRUCAL HbA1c Liquid, Presentation: X 0.25 mL - Level 1: 1 X 0.25 mL / Level 2: 1 X 0.25 mL / Level 3: 1 X 0.25 mL / Level 4: 1 X 0.25 mL, Registration No. 10350840198, lots: 19433-19436, 19949-19952

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 Biosys Ltda; DiaSys Diagnostic Systems 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
    1494
  • Date
    2014-12-26
  • 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
    According to the company's manifestation, since HbA1c is used as a monitoring parameter that takes into account the history of glycemia, a critical impact is not expected in the decision of the therapy, since it will be established taking into consideration other parameters current clinical practice.
  • Cause
    Internal measurements performed by the manufacturer of the product showed that the values ​​obtained with the onhba1c kit (2/3 regent system) calibrated with the cited trucal hba1c batches presented lower values ​​when compared with measurements performed with the hplc comparison system. the manufacturer assumes that the reagent reacts differently when using fresh sample or frozen sample, and the ifcc reference material used for reagent standardization was frozen sample. because of these observations, patient sample values ​​around the endpoints (48mmol / mol as diagnostic cut-off and 53 mmol / mol as therapy target value) are 6-10% lower.
  • Action
    The manufacturer company DiaSys repatriated the reagent using fresh sample as reference material, which was standardized with the HPLC method calibrated by the IFCC material. The registry holder in Brazil forwarded communication on the new standardization and also directed the laboratories to check the need to check the values ​​of patients previously determined

Device

TRUCAL HbA1c Liquid, Presentation: X 0.25 mL - Level 1: 1 X 0.25 mL / Level 2: 1 X 0.25 mL / Leve...

Manufacturer

Biosys Ltda; DiaSys Diagnostic Systems Gmbh
  • Source
    ANVSANVISA