The investigation determined that higher than expected amon results were obtained when a patient sample was tested using vitros amon lot 1018-0255-3934 on a vitros 350 chemistry system.A definitive cause of the higher than expected vitros amon results was not established with the information provided.A vitros amon lot 1018-0255-3934 slide issue cannot be ruled out as a contributor to the event, as no historical qc results were provided to verify the performance of the vitros amon lot 1018-0255-3934 slides.However, qc results on the date of the event were within acceptable guidelines and ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros amon lot 1018-0255-3934.An instrument issue cannot be ruled out as a contributor to the higher than expected results, as no within run diagnostic precision testing was conducted when requested.The customer indicated the patient sample was not hemolyzed, therefore, hemolysis in the patient sample is an unlikely contributor to the higher than expected results.Patient sample mix up cannot be ruled out as a contributor to the event as it could not be determined whether patient sample mix up had occurred for the event.(b)(6).
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