Events

Rappel de Device Recall Medtronic MiniMed Paradigm Insulin Infusion Pumps

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
    64754
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1085-2013
  • Date de mise en oeuvre de l'événement
    2013-03-22
  • Date de publication de l'événement
    2013-04-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-11-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116997
  • 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 paradigm insulin pump because the pump's drive support cap may become detached from the pump case and protrude from the lower right side of the pump. when the pump is expose to water it may result in damage to the pump's internal electronics. this moisture damage can prevent the pump's buttons from working properly or can cause the pump to alarm.
  • Action
    Medtronic sent an Urgent Medical Device Safety Notification letters to all affected customers. The recall letter informs the customers of the problem identified and the actions to be taken. The letter informs the healthcare professionals that Medtronic will inform their patients about the potential safety issues. Customers are instructed to find online information at www.medtronicdiabetes.com/support/product-updates. Customers are instructed to call Medtronic at 1.888.204.7616 (option 1 for loose drive support cap related questions and option 2 for water damage related questions). Distributors are instructed to provide Medtronic with an Excel spreadsheet list of all end users to whom they have shipped any of the listed serialized products.

Device

Device Recall Medtronic MiniMed Paradigm Insulin Infusion Pumps
  • Modèle / numéro de série
    Not available
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) the countries of: AE, AR, AT, AU, BA, BH, BM, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, HU, IE, IL, IN, IQ, IT, JO, JP, KR, KW, LB, LC, LV, MK, MX, MY, NL, NO, NZ, OM, PA, PE, PL, PR, PY, QA, RO, SA, SE, SG, SI, SK, SV, SY, TF, TH, TR, TT, TW, UA, UY, VE, ZA.
  • Description du dispositif
    Medtronic MiniMed Paradigm Insulin Infusion Pumps || Model Numbers: 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. || Product Usage: || Paradigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes.
  • Manufacturer
    Medtronic MiniMed

Manufacturer

Medtronic MiniMed
  • Adresse du fabricant
    Medtronic MiniMed, 18000 Devonshire St, Northridge CA 91325-1219
  • Source
    USFDA