The investigation confirmed that multiple higher and lower than expected vitros phyt results were obtained from two different quality control samples processed on a vitros 350 chemistry system.The investigation was unable to determine a definitive assignable cause.Service actions were performed on the instrument, however, pre-service within-run precision testing used to verify instrument performance was inconclusive.Therefore, an instrument issue cannot be ruled out as a contributing factor.The phyt qc performance was acceptable on both levels of qc prior to the event.This would suggest a vitros phyt slide lot issue is not a likely contributing factor to this event but could not be entirely ruled out.A sub-optimal calibration event occurred prior to the higher than expected phyt results.The cause of the sub-optimal calibration is not known, but it cannot be ruled out as a contributing factor to the higher than expected results.A definitive root cause for the event could not be determined.
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The customer observed multiple higher and lower than expected vitros phenytoin (phyt) results predicted from two different vitros performance verifier quality control fluids processed on a vitros 350 chemistry system.Phyt result for pvi lot l5005 of 9.57, 10.08 ug/ml verses an expected baseline mean of 12.9 ug/ml.Phyt result for pvii lot m5007 of 15.17, 13.54, 15.21, 13.27, 13.05, 26.08, 58.5, 53.9, 58.2, 59.0, 58.5, 59.8, 56.9, 56.4, 59.9, 54.1, 58.8, 58.9, and 54.0 ug/ml verses an expected baseline mean of 21.4 ug/ml.The customer made no allegations that patient sample results were affected.However, biased patient results of the direction and magnitude observed may lead to inappropriate physician action if occurred undetected.There was no allegation of patient harm.This report is number 10 of 21 mdr¿s for this event.Twenty one (21) 3500a forms are being submitted for this event as 21 devices were involved.(b)(4).
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