Events

Recall of USB Communication Data Loss – Handheld Base Unit and Accu-Chek Inform II Base Unit

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Roche Diagnostics Australia Pty Limited.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-00221-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00221-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Model / Serial
    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