Events

Field Safety Notices about JM-103 and JM-105 Jaundice Meters

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Dräger.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2017-12-18
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Our continuous post market surveillance has shown that swedish users have concerns about the method used by the jm-103 and jm-105 to indicate that a taken measurement is out of ränge (higher than the measuring ränge of the device). as described in the instructions for use and in the device’s training materials, the jm-105 displays a blinking o -’ when the measurement is out of ränge. the jm-103 displays blinking “—“ when the measurement is out of ränge. the measuring ränge is defined to 340 pmol/l for both devices.

Device

JM-103 and JM-105 Jaundice Meters

Manufacturer

Dräger