Events

Alerta De Seguridad para ON CALL PLUS STRIPS GLUCOSE TESTS IN BLOOD, Box with 25, 50 or 100 strips, Registration nº 80011990002

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Socinter Sul Comércio Internacional LTDA..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1298
  • Fecha
    2013-09-19
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    According to the manifestation of the company, there are no negative consequences of the use of the product considering the following points: 1) The product is used for monitoring glucose monitoring in neonates and not for diagnosis; 2) The substitution of contraindications for use in newborns by the recommendation of caution in the interpretation of blood glucose levels below 50mg / dl is in line with the current management guidelines for newborns with hypoglycemia, and is identical to that recommended in the use instruction equipment intended exclusively for use with this test strip; 3) The blood glucose values ​​obtained with the On Call Plus Test Strip meet international precision requirements, providing reliable readings that meet the hypoglycemic profile monitoring needs in neonates; 4) Before the product was registered in favor of Socinter, it was marketed under the registration of another company, with the same recommendation of caution in interpreting results in neonates below 50mg / dl; 5) Therefore, considering that the recommended use is what is in the current instruction of use and what is in the registry is what needs to be changed, there are no consequences that could compromise the health and safety of the neonate using the strips of On Call Plus glycemic test. UPDATE - 10/01/2014 - Attachment informative documents for the Hospital Client and the Hospital Distributor.
  • Causa
    The technovigilance unit received a notification of divergence between the package leaf submitted to anvisa and the leaflet of the product currently marketed in brazil. the company was questioned about the divergence and in the investigation process it was identified that in the information regarding "limitations" of the instruction of use submitted to the registry, the guideline is: "do not use for tests with newborns", while in the instruction of use "according to good clinical practice, caution is recommended in the interpretation of glucose values ​​in neonates below 50mg / dl (2.8 mmol / l)".
  • Acción
    The company that registers in Brazil informs that it will forward communication to the services where the On Call Plus blood glucose test strips were marketed and are still within the validity period and where there is potential of use of the product in newborns (general hospitals and maternities) informing about the divergence between the approved text and the current text, clarifying the measures that the company is taking to solve the problem and requesting that, until this problem is solved with the National Health Surveillance Agency, the test strips On Call Plus are not used in the monitoring of hypoglycaemia in neonates. In addition, they will send to these institutions technical documents that support the use of the test strips in neonates, as a way of clarifying the real low-risk condition to the patient. UPDATE - 10/01/2014: The company forwarded documentation stating that it completed the field action. Informs that it sent a communication to Hospital Distributors, General Hospitals and Maternities, considering the cut date for lots valid from September 2011 to September 19, 2013. The company submitted documentation for the evaluation of ANVISA (Management of Diagnostic Products for In Vitro Use (GEVIT / GGTPS), with the justification of the use of Blood Glucose Test Strips On Call Plus in neonates, with documents and scientific articles supporting the recommendation of use in newborns, and the request was approved and published in Official Gazette (DOU) on December 12, 2013.

Device

ON CALL PLUS STRIPS GLUCOSE TESTS IN BLOOD, Box with 25, 50 or 100 strips, Registration nº 800119...

Manufacturer

Socinter Sul Comércio Internacional LTDA.