Investigation summary : the instrument (stago 1) was evaluated by both a field support engineer (fse) and a technical support specialist (tss).The sta-r max instrument was found to be within stago specifications and in good working order.However, an incorrect dilution "correction" factor was discovered for the pc-20 test.This corrector was set to 1 on stago 1 when it should have been 2.This was corrected immediately by the tss.Additionally, middleware data was reviewed by technical experts in the us and the advanced support team at the french manufacturing site reviewed system tracking files, and laboratory information system data provided by the customer.Findings : diagnostics stago has concluded that pc-20 results from (b)(6) 2019 were recovering approximately half of expected levels due the incorrect dilution factor.Root cause: the cause of the pc-20 result issue was an incorrect dilution "correction" factor setting on stago 1.Sna suspects that there was a setting error that originated by human error when stago and customer representatives met in person on (b)(6) 2018.Stago could not definitively confirm this suspected root cause, in part due to the fact that one of the persons directly involved in the meetings is no longer a stago employee and therefore could not be interviewed.Patient impact : we have no information about patients impact but we have to precise that these erroneous results could lead to a wrong treatment.Conclusion : we have concluded our investigations into this event.Please note that a vigilance will be added in the user manuals (sta-r max, sta compact max, sta satellite max) to avoid the problem : user methodology must be validated before releasing results.
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