The customer obtained lower and higher than expected vitros phyt quality control results (vitros tdm n3998 = 11.8, 11.4 and 8.1 versus expected 15.05 ug/ml; tdm p3999 = 14.4, 32.7 and 32.8 versus expected 26.7 ug/ml) processed using a vitros 5600 integrated system.Biased results of the direction and magnitude observed may lead to inappropriate physician action.Although there were no reports of affected patient sample results, it cannot be confirmed that patient sample results were not affected and would not be affected if the event were to recur undetected.There were no allegations of patient harm.This report is number two of six mdr's for this event.Six 3500a forms are being submitted for this event as six devices were involved.(b)(4).
|