The investigation determined higher than expected vitros amon results were obtained from vitros quality control fluids using the vitros amon slides on a vitros 350 chemistry system.A definitive assignable cause could not be determined with the information provided.The customer does not routinely perform amon testing on this analyzer.The analyzer was last used two weeks prior to the event.The customer stated that vitros amon quality control results were acceptable prior to the observed shift on 15 august 2017 when processing the same quality control; however no quality control results were provided to confirm and verify the performance of vitros amon lot 1015-0242-0519 in combination with the vitros 350 system.After the customer recalibrated vitros amon lot 1015-0242-0519 acceptable results were obtained, therefore a reagent issue is not a likely contributor to the event.The sample metering pump leak test failed indicating the vitros 350 system was not performing as expected.The customer performed maintenance actions to address the leak test failure; however the customer calibrated vitros amon lot 1015-0242-0519 without determining if the maintenance actions mitigated the issue.In addition, diagnostic within run precision testing was not performed to evaluate the vitros 350 system performance.Therefore an analyzer related issue could not be confirmed as the cause of the event.
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