Events

Notificaciones De Seguridad De Campo acerca de Dimension Lipase

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 Siemens Healthcare Diagnostics GmbH.

¿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
    2017-12-22
  • 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
    Siemens healthcare diagnostics has received customer complaints regarding a positive bias in qc results and patient samples when using dimension® lipl flex® lot fb8109. siemens internal investigation has confirmed the positive bias with lipl lot fb8109 when compared to other dimension lipl lots. lot fb8109 is not meeting siemens internal specifications for lot-to-lot limits. the investigation compared lot fb8109 with control lot gb8141 (historical performance representative dimension lipase lot). the lot comparison between dimension lipl lot fb8109 and lot gb8141, when using patient samples, demonstrated an average positive bias of 15%. the range of positive bias of 11% (1028 u/l using lot gb8141, as reference lot vs 1141 u/l using lot fb8109) to 22% (94 u/l using lot gb8141 as reference lot vs 114 u/l using lot fb8109). see graph 1 for lot comparison data. .

Device

Dimension Lipase

Manufacturer

Siemens Healthcare Diagnostics GmbH
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    AMPMDRS