The investigation confirmed that a lower than expected vitros creatinine (crea) result was obtained from a single patient sample using the vitros crea slides on a vitros 5,1 fs chemistry system.The investigation was unable to determine a definitive assignable cause.No vitros crea slide performance issues were indicated based on the historical crea quality control data.Ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros crea slide lot 1515-3480-9389.An instrument related event could not be ruled out as a contributing factor as vitros within run precision testing was not performed to evaluate instrument performance.Additionally, pre-analytical sample processing could not be ruled out as a contributing factor.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.There has been no reported recurrence of non-reproducible, lower than expected vitros crea results.A definitive assignable cause for the event could not be determined.
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