Events

Retiro De Equipo (Recall) de ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks. (used with the haemoglobin A1c_3 automated pre-treatment assay intended for monitoring long-term glycaemic control of persons with diabetes). An in vitro diagnostic medical device (IVD).

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Healthcare Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-00983-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-25
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00983-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    The system also allows reporting in either ngsp units (hba1c% = %) or ifcc units (hba1cr = mmol/mol). the ratio equation used to calculate advia chemistry hemoglobin a1c_3 automated pretreatment (a1c_3) results in ifcc units contains an error. the error results in falsely depressed hba1cr results. available data indicates results may be depressed up to -62% (with an average of -18%). this issue does not impact hba1cr results using manual pre-treatment or ngsp units.Falsely depressed results may be considered clinically significant at clinically relevant hba1c values. the risk to health is limited to a potential misinterpretation of glycaemic control or a delay in assessing long-term average hyperglycaemia. when this issue occurs, the potential discordance between average glycaemia and falsely depressed hba1c values may be observed through personal glucose monitoring and/or patient symptoms.
  • Acción
    Siemens is recommending retesting of patients with results above 35 mmol/mol that have been generated in the past 4 months and recommends discussing this issue with the laboratory director. Customers running the currently running the assay using Automated Pre-treatment and reporting results in IFCC units (mmol/mol) are advised to immediately discontinue reporting HbA1cR results. Siemens will be replacing the affected TDef disk with a corrected disk.

Device

ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks. (used with the haem...
  • Modelo / Serial
    ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks. (used with the haemoglobin A1c_3 automated pre-treatment assay intended for monitoring long-term glycaemic control of persons with diabetes). An in vitro diagnostic medical device (IVD).Siemens Material Numbers: 11127343 and 11222123ARTG Number: 175890
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA