Events

Safety Alert for RAPIDLab 1200 SYSTEMS - Registration No. 10345160455; RAPIDPoint 400 Series - Registration No. 10345160460; RAPIDPoint 500 SYSTEM - Registration No. 10345161877. Serial numbers attached to the alert.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos Ltda..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1313
  • Date
    2013-10-16
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    According to the company's statement, mistakes in identifying the sample may lead to the release of incorrect patient results and inappropriate treatment. The clinical results of blood gas analyzers are not interpreted in isolation and inadequate conduct is rare since the physician, through other findings, knows the expected result. Blood gas analyzers are employed in clinical practice and the tests are used to correlate clinical and biochemical findings with optimal treatment and conduct to the patient. Changes in therapy, such as oxygenation rate, would be followed by a repeat test. Patient monitoring would also alert the physician to the potentially discordant outcome, preventing the occurrence of harm.
  • Reason
    Siemens has identified that users may inadvertently enter a wrong patient id on the demographic data editing screen on the rapidpoint® 400, rapidpoint® 500 or rapidlab® 1200 series blood gas analyzers, which could ultimately lead to to an error in the identification of the sample.
  • Action
    To mitigate misidentification, Siemens directs its customers to remove the Patient List button selection; to check demographic data before leaving the demographic data editing screen, to enable only barcode entry, and to keep the letter with the laboratory records. In addition, a mandatory software update must be performed according to the availability of the software.

Device

RAPIDLab 1200 SYSTEMS - Registration No. 10345160455; RAPIDPoint 400 Series - Registration No. 10...

Manufacturer

Siemens Healthcare Diagnósticos Ltda.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA