An internal investigation was performed for falsely over-estimated results when testing three patient samples in association with vidas® tpsa (total prostate specific antigen) lot 1006670400.The analysis of the batch history records for vidas tpsa ref 30428 lot 1006670400/190623-0 showed no anomaly during the manufacturing , control and packaging processes, nor non-conformity linked to customer's issue.The complaint trend analysis confirmed there was no other complaint about not reproducible results on vidas tpsa ref 30428 lot 1006670400/190623-0 control charts analysis observed seven internal samples (target : 0.42- 26.70-4.86-0.38-4.42-20.80-4.74 ng/ml) on seven different batches of vidas tpsa ref 30428 including the customer's lot 1006670400/190623-0.The analysis of the control charts showed that all results are within specifications, and the customer's lot is in the trend of the other lots.The customer's samples were not submitted for evaluation.The complaint laboratory tested three internal samples with the retain kit vidas tpsa ref 30428 lot 1006670400/190623-0.Results from the first test and second test after three days were all within specification.An internal sample was tested with spr (solid phase receptacle) vidas fpsa , and strip vidas tpsa with results of 28.57 ng/l and 2.14 ng/l.The use of a fpsa spr instead of a tpsa spr could explain a decrease of concentration.In conclusion, the root cause was not identified as the samples were not received from the customer.Without samples it was not possible to pursue further investigation.If the operator uses a fpsa spr instead of a tpsa spr, there could be a decrease of concentration.Vidas tpsa ref 30428 lot 1006670400/190623-0 is within the expected performances.
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