The customer stated that they received an erroneous result for one patient sample tested for the elecsys total psa immunoassay (tpsa) on a cobas 6000 e 601 module (e601).The erroneous result was reported outside of the laboratory to the patient.The sample initially resulted as 9.36 ng/ml.The result was doubted based on the patient's previous results.The sample was repeated, resulting as 0.75 ng/ml.The sample was also repeated twice on (b)(6) 2017, each time resulting as 0.75 ng/ml.Repeat testing for another test parameter run on the sample was ok.No adverse events were alleged to have occurred with the patient.The tpsa reagent lot number and expiration date were asked for, but not provided.The customer repeated 5 previous patient samples and all results were ok.The sample run just prior to the complained sample did not have an increased tpsa result.The customer noted that there were sample volume alarms for other tubes and these were confirmed to have low sample volume.There was no hemolysis of the complained sample and the volume was correct.Controls run before and after the complained sample were acceptable.
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