The initial reporter stated that starting (b)(6) 2023 they received questionable results for an unspecified number of patient samples tested with the elecsys vitamin d total iii on a cobas 6000 e601 module, serial number (b)(6).The reporter also mentioned quality control issues.Of the data provided, four patient samples received discrepant results with elecsys vitamin d total iii assay: patient sample 1: the sample initially resulted in a vitamin d total iii value of 45.8 ng/ml and repeated as 29.4 ng/ml.Patient sample 2: the sample initially resulted in a vitamin d total iii value of 61.7 ng/ml and repeated as 35.6 ng/ml.Patient sample 3: the sample initially resulted in a vitamin d total iii value of 44.8 ng/ml and repeated as 28.9 ng/ml.Patient sample 4: the sample initially resulted in a vitamin d total iii value of > 120 ng/ml accompanied by a data flag and repeated as 53.3 ng/ml.The repeat results were deemed correct.The questionable results of patient samples 1, 2, and 3 were reported outside of the laboratory and an amended report was issued.The questionable result of patient sample 4 was not reported outside of the laboratory.
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The calibration performed on (b)(6) 2023 was acceptable with no alarms.On (b)(6) 2023 the customer recalibrated the affected reagent pack twice and the calibration signals shifted higher.The customer replaced the reagent pack and recalibrated twice, with the first calibration's signals matching their initial pack, and the second calibration receiving much higher signals.On (b)(6) 2023 the customer used a new reagent pack and recalibrated it with freshly made calibrators.The calibration was successful with no alarms.On (b)(6) 2023 the quality controls were successful with no alarms.On (b)(6) 2023 the quality controls were partially out of range.On (b)(6) 2023, quality controls were successfully performed on the new reagent pack with no alarms.Upon review of the alarm trace, abnormal probe-sucking errors were observed.These alarms are indicators of possible poor sample quality.After changing the reagent pack and performing a new calibration, the issue did not re-occur.The investigation could not identify a product problem.The cause of the event could not be determined.
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