A customer in the united states notified biomérieux of a qcv failure occurring in position b1 when using the vidas® analyser instrument (ref.99735, serial (b)(4)).The retrospective analysis performed showed an impact on vidas® b·r·a·h·m·s pct¿ (procalcitonin) test results.This qcv failure occurred on (b)(6) 2020.Fse intervention was performed on (b)(6) 2020, and the issue was resolved by a seal replacement.The last conforming qcv was performed on (b)(6) 2020.Qcv failure is not a malfunction; however, it can be associated with incorrect results (prior to qcv failure).Therefore, biomérieux requests customers to conduct a retrospective analysis from the last passed qcv until the present qcv failure.The customer performed a retrospective analysis for samples run in position b1 of the vidas analyser from the (b)(6).During the concerned period of time, for vidas pct, 72 samples were run in position b1.It was indicated that only 26 of these samples were reran in retrospective analysis (other samples were not available).For these 26 samples, the retrospective review determined that three (3) samples had initial underestimated results regardless of the range of expected values for the different indications for use for the vidas pct assay (sepsis or ltri).There is no indication or report from the laboratory that the discrepant results led to any incorrect treatment or any adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.
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