The investigation determined that a discordant, higher than expected vitros ammonia (amon) result was obtained from a patient sample using a new vitros amon slide lot tested on a xt7600 integrated system when compared to a vitros amon result obtained from the sample using the previous vitros amon slide lot tested on the same vitros 5600 integrated system.The assignable cause of the event is user error due to improper storage of the patient sample used in the correlation.The customer could not provide the collection dates or the test dates for the sample when it was tested with the previous vitros amon slide lot, but stated it was likely the sample was stored frozen for greater than 1 month.Per the vitros amon instructions for use, samples stored at =-18 °c (=0 °f) are stable for = 24 hours.The sample was stored greater than 24 hours and is therefore not appropriate for testing with the vitros amon assay.Ammonia is a time sensitive assay due to increase in ammonia concentration as the sample ages.Acceptable vitros amon performance was obtained from non-vitros biorad quality control fluids, vitros liquid performance verifier fluids and vitros calibrator fluids processed as unknown samples, indicating vitros amon slide lot 1929-0264-4179 was performing as intended on the vitros xt7600 integrated system.Therefore, it is unlikely vitros amon slide lot 1929-0264-4179 or the vitros xt7600 integrated system contributed to the event.
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