The initial reporter stated they received discrepant results for three patient samples tested with the elecsys vitamin d total gen.3 assay on a cobas 6000 e 601 module.It was asked, but it is not known if any incorrect results were reported outside of the laboratory.The samples were initially tested on 16-apr-2022 and repeated with dilution.A new reagent pack was placed on board on 17-apr-2022 and control recovery was not good.Calibration signals from the last calibration performed on 13-apr-2022 were higher than expected, so the assay was recalibrated on 19-apr-2022 and the samples were repeated.The first sample initially resulted in a vitamin d value of > 120 ng/ml.The sample was diluted "1/2" and repeated, resulting in a value of 83.1 ng/ml.After recalibration, the sample was repeated on 19-apr-2022, resulting in a value of 29.15 ng/ml.The second sample initially resulted in a vitamin d value of > 120 ng/ml.The sample was diluted "1/2" and repeated, resulting in a value of 51.26 ng/ml.After recalibration, the sample was repeated on 19-apr-2022, resulting in a value of 16.56 ng/ml.The third sample initially resulted in a vitamin d value of > 120 ng/ml.The sample was diluted "1/2" and repeated, resulting in a value of 60.82 ng/ml.After recalibration, the sample was repeated on 19-apr-2022, resulting in a value of 61.60 ng/ml.The serial number of the e 601 analyzer is (b)(4).
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A difference between calibrations performed on (b)(6) 2022 and (b)(6) 2022 could be observed.Each calibration was performed on a different reagent pack.For the calibration performed on (b)(6) 2022 with the first reagent pack, the first level calibrator signals were higher than expected and the second level recovered within expectations.For the calibration performed on (b)(6) 2022 with the second reagent pack, the first level calibrator signals were borderline lower than expected and the second level recovered within expectations.For the first reagent pack, data for only one level of control was provided.Most values were within range, but three values were outside of the second standard deviation range.Measurements performed on (b)(6) 2022 were within range.For the second reagent pack, data for only one level of control was provided.Most values were within range, but two values were outside of the second standard deviation range.A measurement performed on (b)(6) 2022 was within range.Additional quality control data was provided for two levels of control, but it was not clear which reagent pack this was performed on.These controls were within range on (b)(6) 2022 and (b)(6) 2022.The investigation could not identify a product problem.The cause of the event could not be determined.A general reagent issue could be excluded.Updated medwatch field: d4 - expiration date.
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