A customer in the united states contacted biomérieux to report discrepant pct assay results in association with section a-1 of the vidas analyze (s/n (b)(4)).An internal biomérieux investigation was performed.Following this inconsistency, the customer performed a qcv on the vidas analyser s/n (b)(4), which passed on all sections of the instrument.In fact, as detailed in the retrospective analysis file sent by the customer, on (b)(6) 2016, one control (c1) run in section a-1 gave result of 3,44 (error "control out of range") at 9:46, the same control run in section a-1 gave result of 11,24 (error "control out of range") at 10:45.Then, the customer disabled the section a of the instrument.Procedure followed at the customer site: the local field service engineer (fse) visited the customer site on 11 aug 2016 to investigate the reported issue.As indicated in the complaint description, after reporting the discrepant results, the customer performed a qcv in the instrument and all results were conform.The fse checked the problem on the pump in the section a of the instrument, repaired and qualified the instrument.After the reparation and the qualification, he followed an internal checklist.Root cause: the root cause of the discrepant results in slot 1 of the section a was the pump tube, which was partially clogged.Reparation-qualification of the instrument: the biomérieux fse fixed the issue at the customer site by cleaning the pump in section a with the pump cleaner.After the reparation, the fse qualified the instrument by performing a complete leak test on the section a of the instrument.This leak test was conformed.Retrospective analysis: the retrospective analysis was done by the customer.The customer performed the tests from the slot 1 in the section a and in other slots in the other sections of the same instrument.The results of four (4) tests were different.The first results of these tests had been transmitted to the treating physicians but, according to the customer, patient treatment was not adversely affected by the reporting of the original value obtained from samples run in a-1.Conclusion: the root cause of the problem has been clearly identified by the investigation of the biomerieux fse at the customer site.The slot 1 of the section a of the instrument was partially clogged.As a partial clog can react as a leakage in a pump tube, the qcv performed by the customer did not highlight the problem.A partial clog can be highlighted by others mean like the preventive maintenance if the clog is significant enough to have an impact on results, controls performed before each run, and history of the instrument.In this case, the clog in the pump was highlighted by the controls performed two (2) times on slot a1, which were out of range (the 2 control values were completely different one relative to the other).Moreover, several interventions were done to remove clogs on this instrument since the installation ((b)(6) 2014, (b)(6) 2015, (b)(6) 2016).This is a recurrent situation.As a reminder, customer must use the instrument with good quality sample.The instrument has been repaired cleaning the section a pump tubes with the pump cleaner and then the instrument was qualified by performing a leak test.After fse intervention, instrument was qualified and operational.
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