Events

Safety Alert for ADVIA 1200 Chemistry System - Registration No. 10345160456; ADVIA 1650 Chemistry System - Registration No. 10345160453; ADVIA 1800 CHEMISTRY SYSTEM - Registration No. 10345160636; ADVIA 2400 Chemistry System - Registration No. 10345160471. Numbers of series involved - check list attached to this 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
    1320
  • Date
    2013-10-03
  • 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
    The individual tests that make up the most common calculations (eg, Anion GAP, A / G ratio, osmolarity, and estimation of ionized calcium) have clinical utility and are generally reported and revised in conjunction with the calculation result. However, the% HbA1C_3 method may be configured to report only the calculated result. In this case, the calculation will not present the flag and can be reported inadequately, without the proper evaluation of the user, which may lead to an undue evaluation of the glycemic control of the patients. The% HbA1c method is a result calculated from the results of tests A1c and tHb. If a flag is associated with the A1 or tHb test, the calculation of the% HbA1c result will not display the flag if the% HbA1c result is within the defined limits. The result% HbA1c calculation is essential among all calculations, since it alone, and not the individual tHB or A1c tests, has clinical utility to the end user. Only the% HbA1c calculation result is evaluated by the operator. Individual test results from all other common test calculations, such as Anion GAP, A / G ratio, osmolarity, and ionized calcium estimation, have clinical value alone and are evaluated by the operator. #### UPDATED ON 08/18/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • Reason
    Siemens has confirmed that the advia 1200, 1650, 1800 and 2400 chemistry systems report results calculated using ratio parameters without error flags when individual test underlying results are used as part of the calculation are flagged. in cases where the error flag suppresses a numeric result, a ratio calculation will not be performed. if a numerical result is generated with a signaling, the ratio calculation will be reported without signaling.
  • Action
    Siemens recommends its users to: - Identify tests that use parameters calculated on your system and its individual components, these tests should be reviewed before approving the results of the Ratio Parameters test; - Review and evaluate the Flags / Markers associated with individual tests before reporting the calculated test results from Ratio Parameters and; - Review the contents of this letter with the Laboratory Manager and keep the letter in your laboratory records. Please check customer letter (attached to alert)

Device

ADVIA 1200 Chemistry System - Registration No. 10345160456; ADVIA 1650 Chemistry System - Registr...

Manufacturer

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