Events

Retiro De Equipo (Recall) de Sunquest Laboratory

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Sunquest Information Systems, Inc..

¿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
    48174
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0207-2009
  • Fecha de inicio del evento
    2008-04-17
  • Fecha de publicación del evento
    2008-10-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70931
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Calculator/data processing module - Product Code JQP
  • Causa
    Sunquest has identified a problem with igo interfaces when performing an online file cleanup (ofc) that can lead to the test results of one patient filing to another patient when the order codes are the same. performing an ofc prior to all results being assigned an accession number may cause the patient results to remain in a temporary file where they can be incorrectly associated to the wrong pat.
  • Acción
    Customers were sent a preliminary notice on 4/17/2008 followed by customer notice PSN-08-04 on 05/07/2008 via email. The notice advises that this notice is follow-up to the Preliminary notice distributed on 4/17/08 and applies to all clients who have an Instrument Generated Order (IGO) interface. Sunquest has identified a problem with IGO interfaces when performing an Online File Cleanup (OFC) that can lead to the test results of one patient filing to another patient when the order codes are the same. Performing an OFC prior to all results being assigned an accession number may cause the patient results to remain in a temporary file where they can be incorrectly associated to the wrong patient. When this occurs, Sunquest generated reports and inquiry contains the incorrect results. The letter provides the various steps that cause the issue to occur. Sites Potentially Affected by this Problem: Sunquest Laboratory using Instrument Generated Orders (IGO) Interface, Version 5.3 and later Action Sunquest Information Systems is taking to eliminate this Problem: Change Request 1-62VWLJ has been created to address this issue. This will be available as part of Sunquest Laboratory Instrument Build version 1.6.0023 and later. To request the software correction, customers can create a Service request via the Client support Webpage at www.sunquestinfo.com/supportweb. The notice also provides temporary procedural instructions: Effective immediately, do NOT perform Online File Cleanup (OFC) on any IGO instrument interface methods. -Manual OFC should not be performed using functions OFC, or Instrument Maintenance (IX or IXM), option 11 for IGO interfaces only. -If using function Instrument Maintenance (IX or IXM), option 1, 2, 2, Method, 2 (Automatic File Cleanup). This should be set to "N". Then stop and re-start the Instrument Results Processor. Note: Online file cleanup for non-IGO interfaces needs to be performed as usual. -Pending and Overdue Logs need to be monit

Device

Sunquest Laboratory
  • Modelo / Serial
    Sunquest Laboratory versions 5.3, 5.4, 6.1, 6.2 and 6.3.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- including USA and countries of Canada, Bermuda, Ireland, United Kingdom, United Arab Emirates, and Saudi Arabia.
  • Descripción del producto
    Sunquest Laboratory versions 5.3, 5.4, 6.1, 6.2 and 6.3. || Sunquest Laboratory Information System is comprised of several modules which are involved in aspects such as blood banking, collection management, specimen tracking, and use with microbiology and molecular diagnostics. Key capabilities include: || 1) Autoverify results directly from analyzers and reference laboratories || 2) Track tubes and containers from order to final disposition || 3) Monitor key metrics such as turnaround time and utilization using management reports || 4) Produce pathology results with Structured Reports || 5) Suggest microbiology workups online according to defined SOPs and rules || 6) All data entered into the system is accessible through audit trails and Ad Hoc Report tools || 7) Any change to patient results (inquiry, reports) is logged and available for review
  • Manufacturer
    Sunquest Information Systems, Inc.

Manufacturer

Sunquest Information Systems, Inc.
  • Dirección del fabricante
    Sunquest Information Systems, Inc., 250 S Williams Blvd, Tucson AZ 85711-4472
  • Empresa matriz del fabricante (2017)
    Roper Technologies Inc
  • Source
    USFDA