There was an allegation of questionable elecsys folate iii assay results for 8 patient samples on a cobas e 801 module.The initial results were reported outside of the laboratory.The customer was prompted to repeat the samples as they were having calibration and qc issues.For patient 1, the initial folate result was 15.2 ng/ml.The sample was repeated using a new reagent lot and the result was 8.05 ng/ml.For patient 2, the initial folate result was 8.56 ng/ml.The sample was repeated using a new reagent lot and the result was 6.39 ng/ml.For patient 3, the initial folate result was 10.5 ng/ml.The sample was repeated using a new reagent lot and the result was 7.56 ng/ml.For patient 4, the initial folate result was 12.4 ng/ml.The sample was repeated using a new reagent lot and the result was 9.31 ng/ml.For patient 5, the initial folate result was 10.8 ng/ml.The sample was repeated using a new reagent lot and the result was 7.67 ng/ml.For patient 6, the initial folate result was 18.0 ng/ml.The sample was repeated using a new reagent lot and the result was 10.3 ng/ml.For patient 7, the initial folate result was 10.4 ng/ml.The sample was repeated using a new reagent lot and the result was 6.33 ng/ml.For patient 8, the initial folate result was 8.49 ng/ml.The sample was repeated using a new reagent lot and the result was 4.89 ng/ml.The repeat results were deemed correct.The analyzer serial number is (b)(4).
|
Calibration was last performed on 20-oct-2022.Calibration attempts between 20-oct - 02-nov-2022 failed due to low signals.It was found that the calibration signal loss for the affected folate assay lot could be confirmed and was determined to be the root cause of the event.The current workaround as described in a customer communication published in may-2022 involves re-calibrating folate every three days, replacing the reagent pack if calibration fails, and switching to a new reagent lot if calibration and qc fail.
|