Events

Avis De Sécurité sur Miris Human Milk Analyzer

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Miris AB.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2016-05-20
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Manufacturer
    Miris AB

Manufacturer

Miris AB