Events

Retiro De Equipo (Recall) de Device Recall MEDITECH Microbiology

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 Medical Information Technology, 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
    67458
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1124-2014
  • Fecha de inicio del evento
    2014-01-17
  • Fecha de publicación del evento
    2014-03-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-06-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125491
  • 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, for clinical use - Product Code JQP
  • Causa
    Potential for patient results being removed from lab/emr.
  • Acción
    Beginning on January 17, 2014 MEDITECH distributed a notification to MAGIC and Client Server customers who have the Microbiology product in TEST and/or LIVE only for the releases noted in this correction report. This notification was made via e-mailed task updates that can be printed by the customer. Task updates sent via e-mail are immediately transmitted to the customer. Instructions provided to customers: Task Description: CS LAB DTS 11696/MG LAB DTS 16703 - MIC: Inactive procedure prompt not displaying previous results. We are setting up this task to inform you of a potential patient safety issue that may result in patient results being removed from LAB/EMR. This task will continue to be updated to provide you with the status on this issue and details on the deployment of changes to address. This issue has been determined to impact both Client Server and MAGIC 5.6 and higher. Until the changes to address above are delivered, please refrain from inactivating procedure prompts in the MIC Procedure Dictionary. Although patient results are not permanently deleted from the record, because of the potential impact on a patient should this issue occur and go undetected, we felt it necessary to inform you of the issue. We strongly recommend delivery of the changes to address the issue. ¿ We have engaged all necessary resources within MEDITECH to identify and resolve this issue as expediently as possible. ¿ CS LAB DTS 11696 - MIC: Inactive procedure prompt not displaying previous results ¿ MG LAB DTS 16703 - MIC: Inactive procedure prompt not displaying previous results ¿ Inactivating Procedure Prompts in the MIC Procedure Dictionary causes data to be removed from existing specimens. These results are also removed from the EMR. However, once the prompts are re-activated, the results are again present on the specimens. ¿ We strongly recommend delivery of this change to your system to alleviate this potential patient safety concern. Please confirm via this task th

Device

Device Recall MEDITECH Microbiology
  • Modelo / Serial
    Model, catalogue, or product order number(s): MAGIC Releases 5.6, 5. 5.66 and Server Releases 5.6, 5.65. 6.0, 6.05, 6.06, 6.07, 6.1 and 6.13.
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) and to countries of: Canada, Ireland, and United Kingdom.
  • Descripción del producto
    MEDITECH Microbiology - Calculator/data processing module, for clinical use.
  • Manufacturer
    Medical Information Technology, Inc.

Manufacturer

Medical Information Technology, Inc.
  • Dirección del fabricante
    Medical Information Technology, Inc., 7 Blue Hill River Rd, Canton MA 02021-1001
  • Empresa matriz del fabricante (2017)
    Medical Information Technology Inc.
  • Source
    USFDA