[77525076]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[77525077]
The customer complained of erroneous low results for 2 patient samples tested for either elecsys ferritin (ferritin) or cyclosporine on a cobas 8000 e 602 module. Patient 1 initial ferritin result was 0. 653 ng/ml. This result was reported outside of the laboratory where the physician requested the sample be repeated. The sample was repeated without re-centrifuging and the result was 351. 8 ng/ml. Patient 2 initial cyclosporine result was <30 ng/ml. This result was reported outside of the laboratory where the physician requested the sample be repeated. The repeat result from a new, pre-treated sample was 276. 4 ng/ml. There was no allegation that an adverse event occurred. Calibration and quality controls (qc) were within the acceptable range. The measuring cell was exchanged on (b)(6) 2016. The ferritin reagent lot number was 19215400. The expiration date was not provided. The cyclosporine reagent lot number was 15079900. The expiration date was not provided. No issues were identified during a review of the alarm trace. There was an abnormal aspiration alarm on (b)(6) 2017, but this was not at the time of the discrepant results. The assay performance check results were within specification. The last valid calibration for the ferritin reagent was on (b)(6) 2017. Qc results for the ferritin reagent were acceptable. The last valid calibration for the cyclosporine reagent was on 05/15/2017. Qc results for the cyclosporine reagent were acceptable except for qc results on (b)(6) 2017. The customer? S clotting time of 15 minutes is much lower than the manufacturer? S recommended time of 30 minutes. A specific root cause was not identified. Additional information was requested for investigation but was not provided. Based on the calibration and qc results, a general reagent issue at the customer site can most likely be excluded. The most likely root cause of the event is due to pre-analytic issues (short clotting time) or the presence of temporary bubbles or foam on the sample surface. An additional root cause may be insufficient maintenance.
Patient Sequence No: 1, Text Type: D, B5