Events

Alerta De Seguridad para Insulin Reservoirs used with Paradigm Insulin Pump

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Medtronic Inc..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2013-07-03
  • Fecha de publicación del evento
    2013-07-03
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130703.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: medtronic insulin reservoirs used with paradigm insulin pump medical device manufacturer, medtronic inc., has issued a medical device safety alert concerning the model mmt-326a and mmt-332a insulin reservoirs used with paradigm insulin pump. the affected lot numbers in hong kong are h8473271, h8492449 and h8627745. the manufacturer recalls these reservoirs due to the potential that reservoirs from these lots are at increased risk for leaking. a leak in the reservoir may result in delivery of less insulin than intended and, if there is an occlusion in the infusion set, the pump may not alarm. under-delivery of insulin can cause high blood sugar, which if untreated can lead to diabetic ketoacidosis. in most cases, the impact of a leaking reservoir is limited to a temporary increase in glucose levels. the manufacturer received a small number of reports of patients being hospitalized for diabetic ketoacidosis as a result of insulin under-delivery due to the reservoir leaking. the manufacturer has not been aware of any adverse incidents related to the above mentioned issues in hong kong. their investigation has indicated that this increased potential for reservoir leakage is related to abnormal wear of a manufacturing tool involved in the production of a component used in the affected lots of reservoirs. the manufacturer has implemented additional testing and inspection steps to ensure that currently produced reservoirs will not be subject to this problem. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 3 july 2013.

Device

Insulin Reservoirs used with Paradigm Insulin Pump
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic Insulin Reservoirs used with Paradigm Insulin Pump
  • Manufacturer
    Medtronic Inc.

Manufacturer

Medtronic Inc.
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH