Events

Alerte De Sécurité sur Flex Reagent for HB1C Glycosylated Hemoglobin Dimension, Cartridges (6 x 20) + Calibrators (5 x 2mL) - Registration 10345161815. - Batches GA4266; BA4273; BA4280; BA4287; GA4301; GA4315; GC4322; GA4343; GA4350; GA4357; GA5013; GA5020

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..

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
    1446
  • Date
    2014-10-21
  • 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 monitoring of patients with hyperglycemia depends on diet, lifestyle, glucose concentrations, HBA1c and adjustments of therapies for glycemic control. A positive bias of up to 1.0% [11 mmol / mol] for HbA1c may be considered clinically significant at relevant values ​​and may result in modification of therapy for hyperglycemia. Modification of hyperglycemia therapy may increase the risk of hypoglycaemia, which can be observed by monitoring the patient's blood glucose and / or symptoms.
  • Cause
    Siemens has confirmed that the dimension® hb1c flex® kit for lots ga4266; ba4273; ba4280; ba4287; ga4301; ga4315; gc4322; ga4343; ga4350; ga4357; ga5013 and ga5020 present a mean positive bias of 0.4% [4.4 mmol / mol] in hemoglobin a1c and occasionally 1.0% [11 mmol / mol] in hba1c for patients compared to the national glycohemoglobin standardization program (ngsp). controls can display the same performance. depending on the quality control limits, this problem may not have been detected.
  • Action
    The company advises customers to discontinue use of the product, segregate any remaining stock from the affected lot of the HB1C Dimension Glycosylated Hemoglobin Flex Reagent in order to return these products to Siemens and to keep the letter with the laboratory records.

Device

Flex Reagent for HB1C Glycosylated Hemoglobin Dimension, Cartridges (6 x 20) + Calibrators (5 x 2...

Manufacturer

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