Events

Retiro De Equipo (Recall) de V-Lyte Dilution Check & V-Lyte Integrated Multisensor Technology (IMT). 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-2017-RN-00533-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-05-24
  • 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-2017-RN-00533-1
  • 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
    Siemens healthcare diagnostics has confirmed two issues related to the v-lyte integrated multisensor technology (imt) system. the issues regarding the v-lyte dilution check solution and the v-lyte imt system are:1. dilution check relative bias failures - a high rate of dilution check relative bias failures of greater than 2% when using specific lots of v-lyte dilution check solution; and2. integrated multisensor (imt) urine sodium drift - elevated urine sodium quality control (qc) exceeding acceptable qc ranges with the dimension vista imt system. a greater urine sodium drift with urine qc than urine patient samples has been observed. however, not all imt sensors exhibit the described urine sodium qc drift.
  • Acción
    1) For repeated dilution check relative bias failures, Siemens is advising users to contact Customer Care Centre for further assistance. 2) For repeated elevated urine sodium QC drifts, users are advised to load a new Integrated Multisensor Technology (IMT) sensor in addition to coordinating a combination of the steps detailed in the recall letter to minimise or eliminate the drift of urine sodium QC and patient samples as well as to prevent premature sensor replacement and additional troubleshooting. Users are requested to review the letter with their Medical Director.

Device

V-Lyte Dilution Check & V-Lyte Integrated Multisensor Technology (IMT). An in vitro diagnostic me...
  • Modelo / Serial
    V-Lyte Dilution Check & V-Lyte Integrated Multisensor Technology (IMT). An in vitro diagnostic medical device (IVD)V-Lyte Dilution CheckCatalogue Number: K840Material Number (SMN): 10445203Lot Numbers: KC6D01, KC6F01 & KC6J01 V-Lyte Integrated Multisensor Technology (IMT)Catalogue Number: K800AMaterial Number (SMN): 10484429Lot Numbers: 6KD875, 6KD877, 6MD882, 7AD886 & 7BD890 (& future lots until issue resolution)ARTG Number: 181686
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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