Events

Retiro De Equipo (Recall) de DIMENSION VISTA SYSTEM - MAGNESIUM ASSAY

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SIEMENS HEALTHCARE LIMITED.

¿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
    41441
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-09-24
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Siemens healthcare diagnostics has received customer complaints for the dimension vista magnesium (mg) (k3057 10445158) when using lot 15063ba. the complaints were related to erroneous low results on a small number of reagent wells. data collected from the customer complaints shows that there is the potential for under-recovery on certain wells for quality control (qc) and patient sample results. when this issue occurred the under-recovery ranged from -0.3 mg/dl [0.12 mmol/l] to -1.6 mg/dl [0.66 mmol/l]. the average under-recovery was -1.0 mg/dl [0.41 mmol/l]. this issue is demonstrating a low frequency of occurrence with an estimated one (1) in every 10000 tests that may be affected. siemens internal investigations were unable to reproduce this issue likely due to the low probability of occurrence. a root cause investigation is ongoing. repeating the sample on a new well of reagent or a new flex cartridge resolves the issue. this issue is likely to be detected by quality control (qc) or calibrators if they are run on the affected wells of reagent.

Device

DIMENSION VISTA SYSTEM - MAGNESIUM ASSAY
  • Modelo / Serial
    Model Catalog: K3057 (Lot serial: 15063BA)
  • Descripción del producto
    DIMENSION VISTA SYSTEM - MAGNESIUM ASSAY
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Dirección del fabricante
    OAKVILLE
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    HC