Le 5 octobre 2026, la soci\u00e9t\u00e9 Nova Biomedical, bas\u00e9e \u00e0 Waltham (Massachusetts, \u00c9tats-Unis), a annonc\u00e9 avoir engag\u00e9 le 24 juillet 2026 une \u00ab correction de dispositif m\u00e9dical \u00bb au niveau mondial concernant son syst\u00e8me StatStrip Glucose Hospital Meter System, dernier mod\u00e8le dit \u00ab Gen 2.0 \u00bb. L\u2019information a \u00e9t\u00e9 publi\u00e9e par la Food and Drug Administration (FDA) le 6 octobre 2026 dans le cadre de sa communication sur les rappels, retraits du march\u00e9 et alertes de s\u00e9curit\u00e9 relatifs aux dispositifs m\u00e9dicaux.<\/p>\n
Le correctif porte sur un probl\u00e8me logiciel pouvant entra\u00eener l\u2019attribution d\u2019un r\u00e9sultat de glyc\u00e9mie au mauvais patient. Lors du scan du code-barres d\u2019identification patient, les informations du patient pr\u00e9c\u00e9dent peuvent rester affich\u00e9es sur l\u2019\u00e9cran du lecteur et, si elles sont valid\u00e9es, le r\u00e9sultat de glyc\u00e9mie est alors associ\u00e9 au dossier m\u00e9dical du mauvais patient. Si cette erreur n\u2019est pas d\u00e9tect\u00e9e par le professionnel de sant\u00e9, elle peut conduire \u00e0 des d\u00e9cisions cliniques inappropri\u00e9es (retard de traitement, traitement injustifi\u00e9, notamment administration inappropri\u00e9e d\u2019insuline, et\/ou absence de traitement du patient concern\u00e9). Le niveau de gravit\u00e9 d\u00e9pend de l\u2019\u00e9tat glyc\u00e9mique r\u00e9el et de la situation clinique du patient.<\/p>\n
Le probl\u00e8me ne concerne que le mod\u00e8le le plus r\u00e9cent StatStrip Glucose Hospital Meter System \u00ab Gen 2.0 \u00bb et n\u2019affecte pas les versions ant\u00e9rieures identifi\u00e9es comme \u00ab Gen 1.0 \u00bb, \u00ab Gen 1.75 \u00bb, \u00ab Gen 1.86 \u00bb et \u00ab Gen 1.87 \u00bb. La mesure corrective s\u2019applique \u00e0 tous les num\u00e9ros de s\u00e9rie des r\u00e9f\u00e9rences suivantes : StatStrip Glucose Hospital Meter System (part number 63685, UDI 00385480636858, distribution \u00c9tats-Unis et monde), StatStrip Glucose Hospital Meter System multipack (part number 66739, m\u00eame UDI, distribution \u00c9tats-Unis et monde), ainsi que StatStrip Glucose and \u03b2-Ketone Meter (part number 63683, UDI 00385480636834, distribution mondiale hors \u00c9tats-Unis). La distribution est donc globale, avec une port\u00e9e potentielle dans plusieurs syst\u00e8mes de sant\u00e9, y compris hors \u00c9tats-Unis.<\/p>\n
Avant le lancement formel de la correction, Nova Biomedical avait re\u00e7u, le 17 juillet 2026, un signalement d\u2019\u00e9v\u00e9nement ind\u00e9sirable aux \u00c9tats-Unis li\u00e9 \u00e0 ce dysfonctionnement : une administration inappropri\u00e9e d\u2019insuline \u00e0 un patient sur la base du r\u00e9sultat de glyc\u00e9mie d\u2019un autre patient. Aucun \u00e9v\u00e9nement ind\u00e9sirable grave n\u2019a \u00e9t\u00e9 rapport\u00e9 \u00e0 ce stade. La FDA se limite \u00e0 diffuser l\u2019annonce de l\u2019entreprise \u00e0 titre de service public et ne se prononce ni sur le produit ni sur la soci\u00e9t\u00e9. Cette situation soul\u00e8ve des enjeux de s\u00e9curit\u00e9 des dispositifs m\u00e9dicaux num\u00e9riques utilis\u00e9s en milieu hospitalier, en particulier quant \u00e0 la fiabilit\u00e9 de l\u2019identification patient et \u00e0 la pr\u00e9vention des erreurs th\u00e9rapeutiques li\u00e9es \u00e0 des d\u00e9faillances logicielles. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Le 5 octobre 2026, la soci\u00e9t\u00e9 Nova Biomedical, bas\u00e9e \u00e0 Waltham (Massachusetts, \u00c9tats-Unis), a annonc\u00e9 avoir engag\u00e9 le 24 juillet 2026 une \u00ab correction de dispositif m\u00e9dical \u00bb au niveau […]<\/p>\n","protected":false},"author":1,"featured_media":17780,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[7],"tags":[260,227,226],"class_list":["post-20068","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicaments-et-produits-de-sante","tag-fda","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20068","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=20068"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20068\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17780"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=20068"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20068"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20068"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}