The customer called into the siemens customer care center reporting falsely depressed serum results.The issue was identified as a user error.On (b)(6) 2016 the customer had incorrectly changed the serum potassium method comparison coefficients instead of the urine method comparison coefficients on the dimension vista® 500 intelligent lab system, after receiving customer notification (b)(4), dated december 19, 2016.A siemens healthcare diagnostics headquarters support center representative review of vista logfiles for instrument (b)(4) confirms that on (b)(6) 2016 at 11:31 the user logged in as admin changed the potassium (k) coefficients for serum rather than urine as directed in (b)(4).Additionally qc was not processed after this change was made.Review of result data from (b)(4) indicates on (b)(6) 2016 qc was processed at 10:00 without correlation factors applied.At 13:36 the first sample with an e550 correlated notation was reported.All serum samples processed after 11:31 would have the potassium (k) coefficients applied until the issue was corrected on (b)(6) 2016 at 13:32.The customer notification instructed customers that siemens healthcare diagnostics has confirmed a low bias for dimension vista v-lyte integrated multisensor urine potassium (k) when compared to the dimension quiklyte® integrated multisensor, which is the predicate device used in the method comparison section of the v-lyte instructions for use (ifu).This bias affects patient results and qc and could result in failures in accuracy-based proficiency testing programs.The customer notification instructed the customer to change the method comparison coefficients for urine potassium only to compensate for this bias, and new method comparison coefficients were provided.The instructions stated that the correlation factors should be applied to the urine sample type only and emphasized that serum potassium results are not affected by this issue as there are separate parameters for serum potassium.The customer notification provided illustrations of the proper installation of the urine potassium coefficients within the method configuration screen.In this instance, the customer entered the c0 and c1 coefficient values provided into the serum potassium method configuration rather than for the urine potassium method configuration.This error caused the falsely depressed results obtained for serum samples.The issue was resolved by the customer correcting the coefficient values for serum and properly entering the urine coefficients.The correction was verified by qc.The instrument is performing within specifications.No further evaluation of the device is required.
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Discordant, falsely depressed serum potassium (k) results were obtained on qc samples on the dimension vista 500 system.It is unknown if patient results were reported to the physician(s).The qc values returned to within laboratory ranges after an error in the entry of method comparison correlation factors was corrected and higher results were obtained.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed serum potassium results.
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