Events

Rappel de Device Recall MiniMed 620G, MiniMed 640G

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Medtronic Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    76436
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1890-2017
  • Date de mise en oeuvre de l'événement
    2017-01-31
  • Date de publication de l'événement
    2017-04-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153210
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
  • Cause
    Medtronic has identified a software anomaly that can prevent the internal battery of the pump from charging. when the software anomaly occurs it leads to battery depletion and pump shutdown.
  • Action
    A urgent medical device recall letter was sent to customers on 1/31/17 to inform them that Medtronic has identified a software issue that could prevent the internal battery of the pump from charging. Customers are informed that should the software issue occur, an alarm is triggered and they will see the following message displayed on the pump screen: "Power error detected 00:00 25 Delivery stopped. Record your settings by uploading to CareLink or write your settings on paper. See user guide. OK." Customers are informed that If they experience the alarm and see the Power error detected message on their pump accompanied by the number 25, then they are instructed to contact the Medtronic HelpLine team at XXXXX for assistance with troubleshooting the error.

Device

Device Recall MiniMed 620G, MiniMed 640G
  • Modèle / numéro de série
  • Distribution
    Europe, Australia, Japan, Singapore
  • Description du dispositif
    MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these insulin pumps are MMT-1510, MMT-1710, MMT-1711, MMT-1712.
  • Manufacturer
    Medtronic Inc.

Manufacturer

Medtronic Inc.
  • Adresse du fabricant
    Medtronic Inc., 18000 Devonshire Street, Northridge CA 91325-1219
  • 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
    USFDA