Evaluation codes - method, result, and conclusion codes updated.The field service engineer (fse) inspected the instrument, did not identify any specific failure, and was unable to replicate the reported issue.Per review of the data provided by technical support on 31-oct-2019, all latron, start up, and control data were within specifications.Technical support recommended the instrument have the latron nrbc al2 whole blood calibration procedure done because the latron calibration values were within specification but were on the high side.The fse went onsite to perform nrbc and latron calibration on 12-nov-2019.He performed the recommend calibration successfully and provided the calibration data.Review of the data could not confirm an instrument malfunction.A cause for the erroneous unflagged erroneous could not be confirmed.The erroneous un-flagged erroneous results could not be confirmed by the fse.Evidence provided does not allow to confirm if erroneous results were generated or identify a conclusive failure mode.Bec internal identifier - (b)(4).
|