Events

Safety Alert for ADVIA CALIBRATOR FOR INSULIN, INSULIN ADVIA (IRI)

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS || Imported by: SIEMENS S.A...

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
    RDI1705-2
  • Event Number
    I NVIMA2007RD-0000562
  • Date
    2017-05-02
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=90
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    The health agency notifies that siemens healthcarediagnostics, communicates the correction of the adviacentaur system for the insulin test (iri), bearing in mind that in internal investigations siemens has identified that high values are currently being reported, due to the fact that the reference values are not standardized in the in the investigation it was also concluded that the fundamental causes of this problem are related to the raw materials used for the manufacture of the calibrators.

Device

ADVIA CALIBRATOR FOR INSULIN, INSULIN ADVIA (IRI)

Manufacturer

SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS || Imported by: SIEMENS S.A..
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA