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On (b)(6) 2022, a customer in (b)(6) notified biomérieux of underestimated result when testing with vidas® progesterone 60 tests (ref.30409, lot #1009323920, expiry date: 19-may-2023) in context of internal quality control (randox immunoassay) and external quality control (riqas).The internal quality control randox samples processed during august were outside of the manufacturer limits.Expected values: level 1 (imm1): 1.10 - 1.64 ng/ml mean: 1.37 ng/ml.Level 2 (imm2): 10.2 - 15.4 ng/ml mean: 12.8 ng/ml.Level 3 (imm3): 36.3-54.5 ng/ml mean: 45.3 ng/ml.Results on (b)(4) 2022 imm1: 1.23 ng/ml.Imm2: 10.11 ng/ml.Imm3: 32.83 ng/ml.Level 2 (imm2) and level 3 (imm3) samples are out of range low.In addition, the customer tested an external quality control sample: riqas cycle 57 sample 3.The customer's vidas result: 21.83 ng/ml.Comparison mean: 30.27 ng/ml.The customer's results were below the comparison mean.There is no patient associated with these qc samples; therefore, there is no adverse event related to any patient's state of health.A biomérieux internal investigation will be initiated.Reference 30409 is not registered in the united states.The u.S.Similar device is product reference 30409-01.
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This report was initially submitted following notification from a customer in colombia regarding underestimated result when testing with vidas® progesterone 60 tests (reference 30409, lot #1009323920, expiry date: 19-may-2023) in context of external quality control.A biomérieux internal investigation has been completed with the following results: context of the complaint a colombian customer complained about results out of range too low when testing quality control samples on vidas progesterone.The colombian customer tested quality control samples from randox (imm levels 1, 2 and 3) and a quality control sample from an external quality assessment program (riqas cycle 57 sample 3) on vidas® progesterone 60 tests (reference 30409, lot #1009323920).Customers material no material was received from the colombian customer.Investigation outcomes complaint analysis the complaint analysis did not reveal this issue as a systemic quality issue.Quality control records there is neither capa nor non-conformity linked to this issue on this vidas assay.Analysis and tests conducted by complaints laboratory control chart this analysis was carried out: on six (6) internal samples with a respective target at 1.10 / 1.26 / 10.9 / 13.0 / 33.9 and 42.8 ng/ml.On at least nine (9) batches of vidas progesterone including the customer's lot 1009323920.The analysis of the control charts showed that all results are within specifications and the lots mentioned by the customers are in the trend compared to the other lots.Tests performed using internal samples our complaints laboratory tested six (6) internal samples with different targets (same samples as mentioned above) on : vidas progesterone lot 1009453360 and lot 1009323920 as a reference.The results obtained complied to the expectations with no significant difference compared to the results observed before the batch release.So there is no evolution over time of the samples activity.Tests performed using quality control samples from biorad as part of the continuous improvement of our reagent, an adjustment of the calibration curve was implemented on vidas progesterone assay, starting from lot 1009323920, to be better correlated to the reference method gas chromatography mass spectrometry (gc-ms).Based on this information, our complaints laboratory tested quality control samples from biorad level 3 lot 40393 on different lots of vidas progesterone ref.30409.Lot 1009144570 (batch before the action) lots 1009323920 and (lot mentioned by the customers and concerned by the action) lot 1009591390 and 1009453360 (lots used as a reference and also concerned by the action) the results obtained on vidas progesterone lot 1009144570 are higher than the ones observed on the three (3) other lots and within the range provided by biorad.The three (3) other lots, including the lot mentioned by the customer, gave results with no significant difference between them and these results are too low compared to the range provided by biorad.They are in accordance with the range recomputed by our datascience department taking into account the action implemented.Following the improvement, a customer service notification (csn 2022-005-0) with a customer letter was issued in june 2022 to inform customers about this action and that a slight drift may be observed when performing internal quality controls follow-up.It was recommended to adjust the acceptable ranges of these quality control materials (e.G.Apply a probatory period) when using vidas® progesterone kits, starting from the lot number 1009323930.Biomérieux also informed some quality control suppliers (e.G biorad) to inform them about the action.Regarding the issue observed on the external quality assessment program from randox (cycle 57/ sample id 3), without the quality control sample available, it is not possible to explain the result observed by the customer.Moreover, as it is not possible to have the detail of lots used by the vidas peers, we cannot know if the consensus value was obtained using mainly previous lots or new lots concerned by the action implemented.However, based on the analysis of complaints, there is no up rising trend of such issue.Conclusion we did not reproduce the customers anomaly (namely underestimated results) when testing internal samples with different targets.Based on the different testing outcomes, the phenomena observed by the customers can be due to the action implemented on vidas progesterone reference 30409.According to the data mentioned above, there is no reconsideration of vidas progesterone lot 1009323920.
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