Events

Notificaciones De Seguridad De Campo acerca de SPOTCHEM ll Glucose, SPOTCHEM ll PANEL-1 and SPOTCHEM ll PANEL-V

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por ARKRAY Factory, Inc..

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2016-01-28
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notas adicionales en la data
  • Causa
    It was found that a lower reading may be given for the glucose item when the blood glucose concentration of a sample exceeds approximately 350mg/dl. more specifically, when the blood glucose concentrafion exceeds the upper limit of the measurement range (450mg/dl), the message ”over”, indicating that the reading is outside the measurement range, was not displayed and readings of approximately 300~400mgldl may be given. in addition, when within the measurement range, for high glucose concentrations (approximately 350~450mgldl), there is a possibility that the reading may be around -20% of the known concentration. .

Device

SPOTCHEM ll Glucose, SPOTCHEM ll PANEL-1 and SPOTCHEM ll PANEL-V
  • Modelo / Serial
    SPOTCHEM ll Glucose (IVD) (Code77160) Lot: EA5H87,EA5G86,EA5F84,EA5E83,EA5D82,EA5B80,EA5A79 SPOTCHEM ll PANEL-1 (IVD) (Code 77184) Lot : QCSJ49,QC5H48,QC5G47,QC5F46,QC5E45,QC5D44,QC5C43,QCSB42,QC5A41 SPOTCHEM ll PANEL-V (IVD) (Code 77189) Lot : PL5J03,PL5H02,PL5601,PL5F99,PL5E98,PL5D97,PL5C95,PL5894,PL5A93
  • Manufacturer
    ARKRAY Factory, Inc.

Manufacturer

ARKRAY Factory, Inc.
  • Empresa matriz del fabricante (2017)
    Arkray Inc.
  • Source
    AMPMDRS