Events

Rappel de Device Recall Medtronic MiniMed Guardian Monitor

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
    68888
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2179-2014
  • Date de mise en oeuvre de l'événement
    2014-07-21
  • Date de publication de l'événement
    2014-08-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-10-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128937
  • 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
    Sensor, glucose, invasive - Product Code MDS
  • Cause
    Medtronic minimed is recalling the guardian real-time monitors because of a manufacturing issue that has the potential to compromise the water resistance of the affected guardian monitors.
  • Action
    Medical Device Recall letters dated July 21, 2014 andJuly 22, 2014 were sent to distributors, patients, and healthcare providers who purchased the Guardian REAL time monitors. The letters inform the customers of the problems identified and the actions to be taken. Distributors with questions are instructed to email rs.nrdlrinbox@medtronic.com. If healthcare professionals want to speak to Medtronic's medical officers then they are instructed to call (818) 576-4211, ext. 64511. Customers and healthcare professionals' patients are instructed to call Guardian Recall Hotline at (800) 646-4633, ext. 21090, 8am-6pm, CST.

Device

Device Recall Medtronic MiniMed Guardian Monitor
  • Modèle / numéro de série
    CSS7100 and CSS7100K
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide:Distribution - US Nationwide and the countries of Croatia, Denmark, Finland, Germany, Netherlands, Norway, Sweden, Switzerland.
  • Description du dispositif
    Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K || Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combination with the Minilink transmitter and Sof-sensor glucose sensor for continuous monitoring of subcutaneous glucose concentration. The information provided by these devices is intended for use in identifying potential episodes of high or low blood glucose. The information provided is not intended to be used directly for making therapy adjustment but rather to assist the user in determining that an additional fingerstick glucose measurement may be appropriate. Per the product labeling, all therapy adjustments should be based on fingerstick glucose measurements obtained using standard home glucose meters and not on the sensor glucose values provided by the Guardian REAL-Time monitor. The CSS7100 and CSS7100K monitors are identical expect for the fact that the CSS7100K monitor is a pediatric version that has a minimum programmable low alert setting of 90 mg/dL. The minimum programmable low glucose alert setting for the adult model (CSS7100) is 40 mg/dL.
  • 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