Events

Retiro De Equipo (Recall) de CareLink iPro

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 Medtronic 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
    74955
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2898-2016
  • Fecha de inicio del evento
    2016-08-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148899
  • 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
    Continuous glucose monitor retrospective data analysis software - Product Code PHV
  • Causa
    Medtronic minimed is recalling the carelink ipro therapy management software due to a time stamp error.
  • Acción
    Medtronic sent an Urgent Field Corrective Action letter dated August 5, 2016, to affected customers who received the CareLink iPro Therapy Management Software. The letter informed the customers that the recall affects the users of CareLink iPro software who have downloaded reports that include data that was uploaded from certain models of Roche BG meters. Customers were informed that the recall is due to time stamp error and data from certain Roche meters uploaded to CareLink iPro may resulted in incorrect reports. Customers were informed that if they manually enter Logbook data from the Roche ACCU-CHEK meters or upload data from a blood glucose meter other than the Roche meters are not affected by the recall situation. Customers with any questions regarding the recall letter are instructed to contact the Medtronic 24-Hour HelpLine at 1.800.646.4633. For questions regarding this recall call 818-576-4700.

Device

CareLink iPro
  • Modelo / Serial
  • Clasificación del producto
    Clinical Chemistry and Clinical Toxicology Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution to TN, MN, and WA
  • Descripción del producto
    CareLink iPro Version 1.10, Catalog No. MMT-7340 || With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.
  • Manufacturer
    Medtronic Inc.

Manufacturer

Medtronic Inc.
  • Dirección del fabricante
    Medtronic Inc., 18000 Devonshire Street, Northridge CA 91325-1219
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA