Events

Rappel de USB Communication Data Loss – Handheld Base Unit and Accu-Chek Inform II Base Unit

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Roche Diagnostics Australia Pty Limited.

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
    RC-2016-RN-00221-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-03-01
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00221-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Some handheld base units (hbu), used for coaguchek professional meters, cobas h 232 meters and usb communication data loss – handheld base unit, might produce transmission errors in the form of data loss in the usb communication between the meter and the dms. this could happen in rare cases when the base unit is connected via usb connection to a pc. this may be indicated by numerous (nonspecific) error messages sent from the meter to the dms in the form of “unexpected sw failure 11800 events.This issue can lead to the data loss, or in the worst case, to an erroneous assignment of the patient data (patient mismatch). in case of a patient mismatch, taking into account difficult detectability of this issue, a serious medical adverse event cannot be excluded.
  • Action
    A mandatory software update for the “Roche HBU/BU Control Panel” will be required once released by Roche. Until this is available, please do not use the USB connectivity option without further precautions. Roche suggests implementing one of the below workarounds: ·Switch the connectivity method to Ethernet (TCP/IP) or Wi-Fi. ·Install a USB hub or an active USB-repeater to improve the USB signal, to significantly reduce the potential transmission errors. One of these is required per USB connection and the software update will still be required. ·Due to some variances in Base Unit and computer hardware, only specified USB hubs or active USB-repeaters can address the issue - please ask Roche Diagnostics Australia for information. This action has been closed-out on 30/01/2017.

Device

USB Communication Data Loss – Handheld Base Unit and Accu-Chek Inform II Base Unit
  • Modèle / numéro de série
    USB Communication Data Loss – Handheld Base Unit and Accu-Chek Inform II Base UnitVarious affected productsARTG number: 202785 (cobas h 232 POC system)ARTG number:197926 (CoaguChek Professional meters)
  • Manufacturer
    Roche Diagnostics Australia Pty Limited

Manufacturer

Roche Diagnostics Australia Pty Limited