Events

Safety Alert for Jaundice Meter

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Draeger Medical Systems, Inc. || Konica Minolta Inc.

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
    I1703-106
  • Event Number
    2008DM-0002757
  • Date
    2017-03-21
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=96
  • 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 manufacturer reports that medical devices referenced after 1 to 2 years of use may run out of battery after taking some measurements, despite having the battery fully charged, also stresses that with normal use, the meter must be able to take 200 to 250 measurements , this problem is caused by the deterioration of the battery due to a limited charge current, which could lead to delays in patient care.

Device

Jaundice Meter

Manufacturer

Draeger Medical Systems, Inc. || Konica Minolta Inc
  • Source
    NIDFSINVIMA