A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report higher than expected ammonia results obtained from an american proficiency institute (api) sample using vitros chemistry products amon slides on a vitros 4600 chemistry system.Vitros amon lot 1018-0251-7488 on customer vitros 4600 chemistry system: api sample 1 result of 135* umol/l versus an expected result of 101.5 umol/l, (b)(6) 2019.Vitros amon lot 1018-0252-8342 on customer vitros 4600 chemistry system: api sample 1 result of 133* umol/l versus an expected result of 101.5 umol/l, (b)(6) 2019.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The higher than expected vitros amon results were from an api proficiency sample.The customer indicated that no patient sample results were affected.There have been no allegations of patient harm as a result of this event.This report is number 1 of 2 mdr¿s for this event.Two (2) 3500a forms are being submitted for this event as 2 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (b)(4).
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