A customer in the united states notified biomérieux of observing a calibration issue when using vidas brahms procalcitonin 60t (ref.30450-01, batch number 1008952560, expiry date 26-feb-2023).It was reported that rfu values were high.At the time of this assessment, it is not known whether the high rfv concerned the standard or controls.The customer mentioned a delay in reporting results of one day.The number of involved patients is not known.There is no indication or report from the laboratory that the issue led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.
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An internal investigation was performed following notification from a customer in the united states of observing a calibration issue when using vidas® brahms procalcitonin 60t (ref.30450-01, batch number 1008952560, expiry date 26-feb-2023).Investigation review of the device history record did not highlight any issue during manufacturing, control and packaging processes for vidas brahms pct ref 30450-01 batch 1008952560.There is no capa, no non-conformity on vidas brahms pct (ref 30450-01; batch 1008952560) linked with customer's issue.There has been no other similar complaint registered on vidas brahms pct ref 30450-01, batch 1008952560.Calibration was performed with retained kit vidas brahms pct ref 30450-01 batch 1008952560.S1 = 2615 and 2601 rfv ; range = [1994-3561] rfv.S2 = 541 and 532 rfv ; range = [395-705] rfv.C1 = 18.71 ng/ml ; range = [14.20-22.18] ng/ml.C2 = 2.06 ng/ml ; range = [1.52-2.44] ng/ml.Mean value obtained during the control of the batch : s1 : 2849 rfv.S2 : 564 rfv.C1 : 18,19 ng/l.Calibration conformed to specifications (mle data), and the results are similar to those obtained before the release of the batch.The customer anomaly was not reproduced with retained kit vidas brahms pct (ref 30450-01 batch 1008952560).Conclusion.Customer anomaly was not reproduced with the retain kit and biomérieux testing did not reveal any drift of the results from this lot since its release.A field service engineer )fse visited the customer site and observed that the optics wouldn¿t calibrated properly and they were getting optic 160 errors.The fse changed the scanner board, scanner head and solid standard and calibrated optics.Following these repairs, the fse instrument confirmed issue resolution by running a leak test and qcv.There have been no additional issues since the repair.There is no reconsideration of the performance of the vidas brahms pct ref 30450-01 ,batch 1008952560.
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