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 vc-17-01.A.Us, dated december 19, 2016.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.In this instance.Patient samples were run prior to running qc which detected the error.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.Patient results were corrected.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 and patient samples on the dimension vista 500 system.The discordant results were reported to the physician(s).The same samples were repeated after an error in the entry of method comparison correlation factors was corrected and higher results were obtained.Corrected results were reported.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed serum potassium results.
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