The customer stated the qc results for elecsys testosterone ii assay had been running high.They tested a different lot of qc material and the results were still high.Precision testing with qc material was performed and failed.A patient correlation was then performed with previously tested patient samples.One example was provided.The initial result on (b)(6) 2017 was 190.1 ng/dl and the repeat result on (b)(6) 2017 was 276.3 ng/dl.They customer did not know which result was correct and stated questionable results may have been reported outside the laboratory for up to 20 patient samples.Information concerning if any patient was adversely affected was requested but it was unknown.The reagent lot number was 19105304 with an expiration date of 28-feb-2018.The field application specialist took some of the customer's reagents, calibrators, and qc material to another site for troubleshooting.The field service representative found the sipper nozzle needed to be replaced.He replaced the sipper nozzle and the tubing.He ran performance testing which passed.Further investigation found the issue with the sipper nozzle was the cause of the event.A query was performed and found no past or new issues of this nature on any like instruments for the last 12 months at this site.
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