Events

Safety Alert for GENTAMICIN ON LINE TDM

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by ROCHE DIAGNOSTICS GMBH || Importer: PRODUCTOS ROCHE 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
    RRD-030616
  • Event Number
    INVIMA 2010RD-0001796
  • Date
    2016-06-09
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=137
  • 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
    Increase in bias by 15-20% when using reagents referenced with the latest batches of the preciset tdm i calibrator (batches 615118, 619681, 126387, 140735). sometdm controls and quafité external controls also show an increase in bias by 15%. for its part, the control batch tdm 125783 does not show this bias. the change in the used matrix for the production of the preciset tdm i calibrator is probably the source of this drawback. the falsely elevated results of gentamicin could lead to a reduction in the administration of medications.

Device

GENTAMICIN ON LINE TDM
  • Model / Serial
    Reference: 04490843190 - Lots N ° 119166, 611780, 617623 || Reference: 05841291190 - Lots N ° 119167, 611783, 617624 || Reference: 03800504190- Lots N ° 119161, 611779
  • Product Description
    DETERMINATION OF RELATED ANALYTICS IN SAMPLES FROM THE HUMAN ORGANISM.
  • Manufacturer
    ROCHE DIAGNOSTICS GMBH || Importer: PRODUCTOS ROCHE S.A

Manufacturer

ROCHE DIAGNOSTICS GMBH || Importer: PRODUCTOS ROCHE S.A