The customer contacted the siemens customer care center (ccc) to report a discordant low atellica im ca 125ii (ca 125ii) result.Siemens is investigating.The instruction for use (ifu) under the taking corrective action section states the following: "if the quality control results do not fall within the assigned values, do not report results.Perform corrective actions in accordance with established laboratory protocol." the instruction for use (ifu) under the interpretation of results section states the following: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.".
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Siemens filed mdr initial report on 03-jun-2021 for a discordant, falsely low atellica im ca 125ii (ca 125ii) result obtained on a patient sample.04-oct-2021 additional information: siemens has completed the investigation.The customer originally ran the sample on 09-may-2021 with reagent lot 196 (readypack p01519610103552) which resulted low (58.4 u/l).The reagent lot had been last calibrated on 10-apr-2021.Quality control (qc) levels 1 and 2 when run a couple of hours after the discordant result were out of range low.The customer recalibrated reagent lot 196 using the same reagent readypack (p01519610103552) and qc was acceptable.The same patient sample resulted higher (87.6 u/ml) when repeated.The customer when troubleshooting the issue performed addition testing (12-may-2021) with the same patient sample, same reagent readypack (p01519610103552), resulting higher (88.5 u/ml).The same patient sample when run again on 12-may-2021 with a new reagent readypack resulted higher (132.2 u/ml).This sample when run was not within the instructions for use (ifu ) sample handling recommendations.All atellica im ca125ii results generated on this patient were all greater than 30.2 u/ml (ifu 97.5% upper limit of normal).Based on the information provided, the potential cause for the varying results on this patient's sample may be attributed to the recalibration performed on 09-may-2021 with reagent readypack p01519610103552.The atellica im ca 125ii assay has an increased sensitivity to light exposure.It was observed that atellica im ca 125ii reagent readypacks were not stored in the reagent kit boxes.Siemens cannot rule out an issue with the reagent readypack and potential light exposure as quality control (qc) was out of range low at the time of the observed issue.A precision study check was performed at the customer site on patient samples, qc, and master curve material and the results were within acceptable limits.A product performance issue was not observed.The customer is operational.The instructions for use (ifu) under the storage and stability section states the following: "store reagents in an upright position.Protect the product from heat and light sources." the assay is performing within specifications.No further evaluation of the device is required.In section h6, the investigation findings code and the investigation conclusion code were revised.
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