Medical device manufacturer, Roche Diagnostics, has issued a medical device safety alert concerning its cobas 8000 modular operator's Manual version 5.0. The systems affected are cobas e 602 module (catalogue number 05990378001) and cobas e 801 module (catalogue number 07682913001).
The manufacturer is informing customers that they found discrepant information between the previous versions 4.2.1 and 5.0 cobas 8000 operator's manuals (OM) for non-standard tubes (NSTs). The version 5.0 OM incorrectly states that 11 to 16 mm diameter NSTs may be used on cobas e 602 and cobas e 801 modules. However, only NST diameters of 13 to 16 mm are permitted on these modules.
Only the version 5.0 cobas 8000 OM was incorrect for minimum NST diameter on the cobas e 602 and cobas e 801 modules. All previous OM versions correctly specified a 13 to 16 mm NST diameter for tile cobas e 602 module. According to the manufacturer, if a sample tube with a too narrow diameter (<13 mm) is used on a cobas e 602 or cobas e 801 module, the implemented safety features on both these modules should ensure with a very high probability that a sample result is not generated in the event of the sample probe coming into contact with the inner wall of the tube during sample aspiration.
However, as the said safety features on the cobas e 602 and cobas e 801 modules are designed to work specifically and optimally with NSTs of 13 mm to 16 mm diameter (and not 11 mm), while the actual risk can be considered low, a wrong result still cannot be ruled out with 100% certainty in the event of NSTs with less than 13 mm diameters being used on cobas e 602 and cobas e 801 modules.
The manufacturer advises users to ensure that only tubes with a diameter of 13 to l6 mm are used on cobas e 602 and cobas e 801 modules. Furthermore, the just launched version 5.1 cobas 8000 operator's manual (which supersedes version 5.0) now correctly states that only 13- 16 mm diameter NSTs may be used on cobas e 602 and cobas e 801 modules. Users should replace any available version 5.0 cobas 8000 operator's manual by the version 5.1 cobas 8000 operator's manual, which states the correct non-standard tube specifications.
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 28 February 2017