Events

Rappel de Device Recall Medtronic MiniMed Paradigm REALTime and Paradigm REALTime Revel CGM System and MiniMed 530G System

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 MiniMed 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
    68277
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2544-2014
  • Date de mise en oeuvre de l'événement
    2014-03-13
  • Date de publication de l'événement
    2014-08-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-04-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127259
  • 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
    Pump, infusion, insulin, to be used with invasive glucose sensor - Product Code OYC
  • Cause
    Medtronic is recalling the medtronic minimed paradigm insulin infusion pumps because they have received reports that users have accidentally programmed the pump to deliver the maximum bolus amount.
  • Action
    The firm, Medtronic, sent an "IMPORTANT MEDICAL DEVICE SAFETY INFORMATION" letter dated March 13, 2014 to its customers. The letter described the product, problem and actions to be taken. The letter informs the customers that because accidental button pressing errors may occur it is important that customers always confirm the insulin dose flashing on the display is correct before pressing ACT to start delivery. The letter informs the customers of what safety settings will minimize the risk of an accidental programming error and what actions to be taken. Should you have any questions about this letter or concerns with your keypad, please do not hesitate to contact the 24 hour helpline at (866) 222-7304 for a replacement.

Device

Device Recall Medtronic MiniMed Paradigm REALTime and Paradigm REALTime Revel CGM System and Min...
  • Modèle / numéro de série
    Paradigm: MMT-523NAB, MMT-723KNB, MMT-523NAH, MMT-723KNH, MMT -523NAL, MMT-723KNL, MMT-523NAP, MMT-723KNP, MMT-523NAS, MMT-723KNS, MMT-723NAB, MMT-723NAH, MMT-723NAL, MMT-723NAP, MMT-723NAS, MMT-523KNB, MMT-523KNH, MMT-523KNL, MMT-523KNP, MMT-523KNS.  MiniMed 530G: MMT-551NAM, MMT-551NAH, MMT-551NAL, MMT-551NAP, MMT-551NAS, MMT-751NAB, MMT-751NAH, MMT-751NAL, MMT-751NAP, MMT-751NAS.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-Nationwide in US
  • Description du dispositif
    Medtronic MiniMed Paradigm Insulin Infusion Pumps, || Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. || MiniMed 530G: MMT-551, and MMT-751 || Paradigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes.
  • Manufacturer
    Medtronic MiniMed Inc.

Manufacturer

Medtronic MiniMed Inc.
  • Adresse du fabricant
    Medtronic MiniMed Inc., 18000 Devonshire St, 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