Events

Rappel de Insulin infusion pump (as part of the ACCUCHEK Aviva Combo 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 Roche Diagnostics Operations, 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
    69323
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0146-2015
  • Date de publication de l'événement
    2014-10-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130228
  • 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 - Product Code LZG
  • Cause
    The insulin pump may lose time and date settings during a power interruption (such as a battery change) due to a faulty capacitor. if the capacitor fails, the time and date will return to default setting. though the pump prompts customers to confirm the time and date, if the user does not recognize the time and date have returned to default, a shift of their basal rate time block could occur.
  • Action
    Roche sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated September 25, 2014 via UPS Ground (receipt required) to the consignees. The letter included a description of the reason for recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. No product returns were expected. For questions, contact the ACCU-CHEK Customer Care Service Center at 1-800-688-4578.

Device

Insulin infusion pump (as part of the ACCUCHEK Aviva Combo system)
  • Modèle / numéro de série
    Model/Catalog/Part Number:  Accu-Chek Combo Kit mg US/English version, 05458544001  Accu-Chek Combo Kit mg US/Spanish version, 055004686001  Accu-Chek Spirit Combo Replacement Pump US/EN, 05391512001  Accu-Chek Spirit Combo Demo Pump- US, 0539175000
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution in the states of CA, CT, IA, NV, OH, IN, WI, GA, MO, NY, VA, LA, ME, TX, NC, ND, SD, NJ, CO, AL, SC, IL, KY, FL, OR, MN, MD, MS, AR, WV, WA, TN, CT, ID, KS, MI, PA, UT, MA, RI, NM, OK, DE, AZ, NE, MT, NV, WY, AK, and NH.
  • Description du dispositif
    ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System || Product Usage: || The ACCU-CHEK Combo System is meant only for single-patient use; the device may not be used for screening or diagnosis of diabetes or for multiple patient use. It is indicated for the treatment of insulin requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger. The ACCU-CHEK Spirit Combo Insulin Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician.
  • Manufacturer
    Roche Diagnostics Operations, Inc.

Manufacturer

Roche Diagnostics Operations, Inc.
  • Adresse du fabricant
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Société-mère du fabricant (2017)
    Roche Holding AG
  • Source
    USFDA