The investigation confirmed that unexpected vitros amon results were obtained using two levels of non-vitros quality controls and a single level of vitros quality control tested on a vitros 5600 integrated system.The most likely assignable cause of the unexpected vitros amon quality control results is an instrument related issue.The results of amon within-run precision testing demonstrated that the vitros system was not operating as expected.Following service actions that optimized all subsystems of the vitros 5600 integrated system, including the replacement of evaporation caps and wear pads, along with all necessary adjustments, acceptable vitros amon performance was observed.
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The investigation determined unexpected ammonia results were obtained from two levels of a non-vitros biorad quality control fluids and a single level of vitros liquid performance verifier (lpv) when using vitros amon slides on a vitros 5600 integrated system.Br l2 lot 54162 vitros amon result of 105.0 umol/l versus expected 87.3 umol/l.Br l3 lot 54163 vitros amon result of 178.4, 58.2 and 97.5 umol/l versus expected 226.6 umol/l.Lpv l1 lot u4561 vitros amon result of 110.0 umol/l versus expected 37.6 umol/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action, should they occur undetected on patient samples.The customer stated that patient samples were not processed during the timeframe the quality control results were outside of established ranges, however the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected.There was no reported allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.(b)(4).
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