Events

Rappel de Device Recall AccuChek Inform II Blood Glucose Monitoring 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
    73253
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1172-2016
  • Date de mise en oeuvre de l'événement
    2016-02-11
  • Date de publication de l'événement
    2016-03-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-05-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143632
  • 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
    Glucose dehydrogenase, glucose - Product Code LFR
  • Cause
    Accu-chek inform ii base unit might produce physical transmission errors in the form of data loss in the communication between the meter and the data management systems (dms). the issue can lead to the data loss or in the worst case to an erroneous assignment of the patient data (patient mismatch). the issue will only occur at sites using potct1-a communication via usb.
  • Action
    Roche sent an URGENT MEDICAL DEVICE RECALL CORRECTION letter dated February 11, 2016, via UPS Ground (receipt required) to the consignee. The Consignee instructions were as follows: ¿ If currently using USB connectivity, follow the instructions outlined in this Urgent Medical Device Correction (UMDC) to determine if your base unit is affected by the issue. ¿ Until the new software is available, do not use USB connectivity if the base unit is affected by this issue; switch the connectivity method to Ethernet (TCP/IP) or Wi-Fi. Roche is not requesting return of affected product. Any returned product will be managed according to current procedures. Consignees with questions were instructed to contact the ACCU-CHEK Customer Care Service Center at 1-800-440-3638. For questions regarding this recall call 317-521-3911.

Device

Device Recall AccuChek Inform II Blood Glucose Monitoring System.
  • Modèle / numéro de série
    Model/Catalog/Part Number: 05060290001; serial numbers: UU41000000 through UU41064963 and UU41064964 through UU41122741.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, and WV.
  • Description du dispositif
    Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitoring System || Accu-Chek inform II Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings. This system should only be use with single-use, auto-disabling lancing devices.
  • 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