| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00221-1 |
| Product Name/Description |
USB Communication Data Loss – Handheld Base Unit and Accu-Chek Inform II Base Unit
Various affected products
ARTG number: 202785 (cobas h 232 POC system)
ARTG number:197926 (CoaguChek Professional meters) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
1/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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. |
| Contact Information |
(02) 9860 2222 - Roche Diagnostics |