A discordant, falsely low total bilirubin result was obtained on one patient sample upon repeat testing on a dimension vista 500 instrument.The initial result had been higher and was reported to the physician(s).The discordant, falsely low result was also reported to the physician(s), who questioned it.The operator issued a corrected report with the initial result, which matched the clinical picture of the patient.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low total bilirubin result.
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The initial mdr 2517506-2017-00662 was filed on aug 21, 2017.Additional information (08/29/2017): a siemens headquarter support center (hsc) specialist reviewed of the information available.The result was flagged with a below assay range.As per the vista operator's guide for the reporting of results with below assay range flags: "explanation: the result is below the assay range and cannot be calculated.What to do: confirm that there was enough sample volume and that there were no error messages.Follow laboratory specific procedures, which may include rerunning or diluting the sample with one part sample to one part known standard or qc material.".
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