A discordant, falsely depressed urine enzymatic creatinine result was obtained on a patient sample on a dimension vista 1500 instrument.The initial result was flagged with an "e512 below reference range" flag and was reported out to the physician(s), which was questioned.The customer repeated the same sample on the same dimension vista instrument, resulting higher.The customer repeated the same sample on an alternate dimension vista instrument, resulting higher than the initial result.The customer issued a corrected reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely depressed urine enzymatic creatinine result.
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The initial mdr 2517506-2017-00265 was filed on march 16, 2017.Additional information (03/27/2017): the siemens customer service engineer (cse) was dispatched to the customer's site.The cse replaced the aliquot probe and sample probe.The user has not experienced any further issues.The cause of the discordant, falsely depressed urine enzymatic creatinine result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.
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