Medical device manufacturer, Roche, has issued a medical device safety alert concerning its cobas 6500 urine analyzer series [cobas u 701 microscopy analyzer in combination with cobas u 601 urine analyzer; Software version 2.2.0 - 2.2.8].
The manufacturer has received one complaint regarding a possible sample mismatch on the cobas 6500 urine analyzer series with software version 2.2.7 (Windows Embedded POSReady 2009). The mismatch was detected by the customer due to discrepant results between the cobas u 601 urine analyzer and cobas u 701 microscopy analyzer for the same sample. In this case, there was no reported adverse impact to the patient. The issue was investigated and confirmed.
According to the manufacturer, a mismatch of results of cobas u 601 urine analyzer and cobas u 701 microscopy analyzer for the same sample was observed after a cuvette solid waste container-full error message 70401 came up on the user interface of the cobas 6500 urine analyzer series.
Although only one complaint case since 2014 has been reported to the manufacturer, the issue can theoretically lead to wrong assignments of results and therefore may affect clinical interpretation.
The manufacturer has initiated the following actions: development, verification, distribution and implementation of a corrected software version 2.2.9 (Windows Embedded POSReady 2009) for cobas 6500 urine analyzer series.
Affected users are advised to empty the cuvette solid waste container every time a new cuvette cassette gets loaded onto the cobas u 701 microscopy analyzer and not to use the stop button on the user interface of the cobas 6500 urine analyzer series.
The advice is valid as long as the cobas 6500 urine analyzer series with software versions 2.2.0 - 2.2.8 is in use. The issue will be resolved with the update to software version 2.2.9. The manufacturer will proactively contact affected users for the software upgrade appointment when it is available.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 April 2020