Events

Alerte De Sécurité sur Insulin Reservoirs used with Paradigm Insulin Pump

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Medtronic Inc..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

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  • Type d'événement
    Safety alert
  • Date
    2013-07-03
  • Date de publication de l'événement
    2013-07-03
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130703.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medtronic Insulin Reservoirs used with Paradigm Insulin Pump
  • Manufacturer
    Medtronic Inc.

Manufacturer

Medtronic Inc.
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “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