Events

Rappel de Device Recall PARADIGM QUICKSET INFUSION SET

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.

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
    52521
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1705-2009
  • Date de mise en oeuvre de l'événement
    2009-06-29
  • Date de publication de l'événement
    2009-07-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-11-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83186
  • 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
    Set, administration, intravascular - Product Code FPA
  • Cause
    Approximately 2% of the infusion sets in the affected lots may not allow the insulin pump to vent properly. venting is necessary to equalize the pressure in the syringe compartment with the surrounding atmosphere. if the vent does not work properly, this could potentially result in too much or too little insulin being delivered.
  • Action
    Medtronic issued an "URGENT MEDICAL DEVICE RECALL" notification letter dated July 6, 2009 to health care professionals, followed by notification letters dated July 7, 2009 to distributors, inactive and active customers. Letters to healthcare professionals and distributors were sent via UPS 2-Day Air with signature confirmation of delivery required. On July 8, 2009 and July 9, 2009, a notification letter, along with replacements sets, were mailed via UPS to active patients or customers (who have ordered since January 2009). The notification letter to patients (inactive customers) who last ordered prior to January 1, 2009 were issued via First Class U.S. Mail. All letters to patients include a preaddressed, postage paid card to confirm that the patient has received the recall notice and to identify whether or not they have unused sets to return. As described in the patient letters, patients have the option to confirm receipt of the notification and to order replacement infusion sets online or via an automated telephone voice response system. Distributors who purchased affected Paradigm Quick-set infusion sets must either notify all patients to whom they have provided infusion sets or provide patient names and addresses to Medtronic MiniMed so that the firm can carry out the notification. The firm's website, www.medtronicdiabetes.com/lot8, is available for customer concerns and questions not addressed in the recall letter. The website is also the most efficient way to exchange Lot 8 Quick-set infusion sets and/or place new supply orders. In the event the above website is not accessible or for additional questions, please call 1-800-345-8139 at Medtronic Diabetes 24- hours a day. Doctors who would like to speak with a Medtronic Diabetes medical officer may call 1-818-576-4211, 24-hours a day. Report product problems by calling 1-800-345-8139 at any time. Medtronic issued a press release on July 10, 2009.

Device

Device Recall PARADIGM QUICKSET INFUSION SET
  • Modèle / numéro de série
    Lot numbers starting with the Number 8.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US, Canada, Mexico, Bermuda, Brazil, United Kingdom, Ecuador, Paraguay, Kuwait, Germany, El Salvador and Turkey.
  • Description du dispositif
    Paradigm Quick-set Infusion Sets, Models MMT-396, MMT-397, MMT-398 and MMT-399. || The Paradigm Quick-set infusion sets are intended for use in combination with Paradigm reservoirs (models MMT- 326 or MMT-332) and Paradigm external insulin infusion pumps to deliver insulin (subcutaneously) to patients who require exogenous insulin to maintain glycemic control.
  • Manufacturer
    Medtronic MiniMed

Manufacturer

Medtronic MiniMed
  • Adresse du fabricant
    Medtronic MiniMed, 18000 Devonshire St, Northridge CA 91325
  • 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