The initial reporter stated they received discrepant results for three patient samples tested with a1c-3 tina-quant hemoglobin a1c gen.3 on a cobas 6000 c (501) module.The third patient sample also had a discrepant hba1c result when tested on a second c 501 analyzer.The samples have a negative bias in hba1c values when compared to values measured on a dca advantage analyzer.The first patient sample resulted with an hba1c value of > 14.0 % when tested on the dca analyzer.The sample was repeated on the first c 501 analyzer, resulting with a value of 11.3 %.Both analyzer values were reported outside of the laboratory and no corrected reports were issued.The second patient sample, from a (b)(6) male patient born on (b)(6), resulted with an hba1c value of > 14.0 % when tested on the dca analyzer.The sample was repeated on the first c 501 analyzer, resulting with a value of 11.2 %.Both analyzer values were reported outside of the laboratory and no corrected reports were issued.On (b)(6) 2020, the reporter ran linearity materials on the dca analyzer and these recovered acceptably.The same linearity materials were tested on the c 501 and failed with negative bias.On (b)(6) 2020, the first sample was repeated on a second dca analyzer, resulting with a value of 11.7 %.On (b)(6) 2020, the second sample was repeated on a second dca analyzer, resulting with a value of 13.2 %.On (b)(6) 2020, the customer checked calibration data for the first c 501 instrument and determined the last hba1c calibration was performed on (b)(6) 2019.The test was then re-calibrated and linearity materials were repeated on this c 501 instrument.On (b)(6) 2020, the first sample was repeated on the first c 501 analyzer, resulting with a value of 11.7 %.On (b)(6) 2020, the second sample was repeated on the first c 501 analyzer, resulting with a value of 11.4 %.The field service engineer checked the first c 501 system on 24-jan-2020 and determined there was an issue with fluidics.The sample probe was replaced.The rinse mechanism was checked and probe volumes were checked.The gear pump pressure and mixers were adjusted.The customer ran controls and these recovered near the mean.After service was performed, the customer ran the linearity materials again on the first c 501 analyzer and linearity failed at the high end of the measuring range.On (b)(6) 2020, the third patient sample from a (b)(6) female patient born on (b)(6), initially resulted with a value of > 14 % when tested on the dca analyzer.The sample was repeated on the first c 501 analyzer, resulting with a value of 11.6 %.The serial number of the first c 501 analyzer is (b)(4).
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The reporter mentioned that on (b)(6) 2020, they had three samples with hba1c results that were higher on the c501.All three resulted with values of >14% accompanied by a data flag on the dca but anywhere between 12.1-12.7 % on the c501.No incorrect results were reported outside of the laboratory.It was asked, but it is not known if the dca and c501 measurements were performed with samples collected from the patient at the same time or if each measurement was performed using a different sample collected from each patient at a different time.Calibration data looked good, however while investigating the issue on 23-jan-2020, the last calibration date was checked and found to be 22-dec-2019.Product labeling states the reagent is stable for 28 days onboard.The assay settings were checked in the instrument and it was found that calibration only occurred when new lots were started.The customer has decided to recalibrate every 2 weeks.Upon review of the alarm trace, sample short alarms, abnormal probe aspiration alarms, and a sample cup type read error occurred on 14-jan-2020.The field service engineer determined there was a fluidics issue with the sample probe.The probe was replaced.The rinse mechanism and probe volumes were checked.The gear pump pressure and mixers were adjusted.The customer ran controls and these recovered near the expected mean.The investigation determined the service actions resolved the issue.
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