The initial reporter stated they received questionable results for samples from two patients tested with the elecsys free psa and the elecsys total psa assay on a cobas e 801 module.The free psa values were greater than the total psa values.The questionable results were not reported outside of the laboratory.This medwatch will apply to the free psa assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the total psa assay.Patient 1: on (b)(6) 2023, the sample initially resulted in a free psa value of 0.0138 ng/ml and repeated as 0.0138 ng/ml.On (b)(6) 2023, the sample initially resulted in a total psa value of < 0.006 ng/ml, accompanied by a data flag.Patient 2: on (b)(6) 2023, the sample initially resulted in a free psa value of 0.0114 ng/ml.On (b)(6) 2023, the sample was repeated, resulting in a free psa value of 0.0105 ng/ml.On (b)(6) 2023, the sample initially resulted in a total psa value of < 0.006 ng/ml, accompanied by a data flag.On (b)(6) 2023, the sample initially resulted in a total psa value of < 0.006 ng/ml, accompanied by a data flag.The serial number of the cobas e 801 module is (b)(6).
|
The field service engineer found an issue with the reagent probe and crystallization in the pre-wash rinse station.The rinse stations, sample and reagent probes, and pre-wash flow paths were cleaned.Measuring cell preparation was performed.These maintenance issues were not related to the reported event.The patient samples were requested for investigation but could not be provided.Based on the information provided, a general reagent-related issue can be excluded.The reagent performs within specifications.The investigation did not identify a product problem.The cause of the event could not be determined.
|