Events

Retiro De Equipo (Recall) de AMM Flex Reagent Cartridge used with Dimension Clinical Chemistry System Assay: Ammonia (AMM)

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-00349-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-03-14
  • 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-00349-1
  • 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
    In september 2014, siemens healthcare diagnostics issued customer notification dc 14-09 that addressed a high rate of “abnormal assay” test report messages for its dimension ammonia (amm) assay. internal testing revealed that the “result monitor below” mean factor for ammonia (ammdf119) is set with a narrow limit, which may cause some ammonia results to be inappropriately flagged with an “abnormal assay”. flagged amm “abnormal assay” results may be attributed to a contamination of open wells of the amm flex reagent cartridge. quality control (qc) and patient samples may be affected; however, affected results are appropriately flagged.
  • Acción
    Siemens is reducing the AMM open well stability from 3 days to 1 day (24 hours) and providing instructions for managing this change. Dimension AMM IFU revision E will reflect this change. The new version of Dimension software, 10.2, will do the following: - Automatically move to a new well every day. This decrease in the open well maximum duration reduces the amount of time the AMM reagent is exposed to any potential contaminates, reduces the need for customers to manually move to a new reagent well, and aids in the prevention of erroneous flagging. - Contain the Below Mean Factor limit of 0.90. Users are notified that until Dimension 10.2 software is installed on their instruments, manually move to a fresh AMM well of reagent every day. Also, to reduce the likelihood of false AMM “Abnormal assay” messages, verify that the Below Mean Factor for the Result Monitor is set to the revised limit of 0.90 by following instructions provided in the customer letter.

Device

AMM Flex Reagent Cartridge used with Dimension Clinical Chemistry System Assay: Ammonia (AMM)
  • Modelo / Serial
    AMM Flex Reagent Cartridge used with Dimension Clinical Chemistry System Assay: Ammonia (AMM)Catalogue Number: DF119Siemens Material Number (SMN):10711991Lot Numbers: All in-date lotsARTG Number: 181689
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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