The investigation determined that lower than expected vitros phyt results were obtained from a single patient sample using a vitros 5600 integrated system.A likely assignable cause for the lower than expected vitros phyt results could not be determined, however, an unexpected instrument or a reagent issue cannot be ruled out as contributing factors.In addition, pre-analytical sample processing could not be ruled out as a contributing factor.Cellular debris, due to poor sample preparation, may have been present in the affected sample, although this could not be confirmed.The definitive assignable cause for the event is unknown.
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The customer observed multiple, non-reproducible, lower than expected vitros phyt results obtained from a single patient sample processed on a vitros 5600 integrated system.Patient phyt:7.5, 9.6, 8.5, 8.5 and 9.3 ug/ml versus expected 12.0ug/ml biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The lower than expected vitros tropi es results associated with patient 1 were not reported from the laboratory.There was no allegation of patient harm as a result of the event.This report is number one of five mdr's for this event.Five 3500a forms are being submitted for this event as five devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4) and (b)(4).
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