Events

Field Safety Notices about Miris Human Milk Analyzer

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 Miris AB.

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
    2016-05-20
  • 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
    We are contacting you regarding an incident report filed to the swedish medical products agency. the incident concerned inaccurate programming ofan hma used for nutritional analysis ofhuman milk. the error was found only at analysis on the instruments calibration for unhomogenized milk, where the protein levels were overestimated. miris takes this incident very seriously. without further investigation of each instrument we are unable to rule out that no other instruments are also affected by the error, which may lead to incorrect nutrition of preterm infants. therefore, miris recommends users to stop using the hma for fortification purposes in nutritional care of pre-term infants until the instrument has been controlled and validated by miris staff.

Device

Miris Human Milk Analyzer

Manufacturer

Miris AB