The initial reporter stated they had issues with control recovery for mg2 magnesium gen.2 on a cobas 6000 c (501) module.Quality controls were acceptable at the beginning of the shift, but on the next shift, they were unacceptable.When qc failed, the magnesium reagent kit had about 10 tests left.This kit was recalibrated, but controls still failed.The customer discarded the reagent kit and loaded a new kit that had successful qc.13 patient samples were repeated on (b)(6) 2021 using the new reagent kit because the initial results were higher than expected.Of the thirteen samples, ten samples had discrepant magnesium values.The initial values for these samples were reported outside of the laboratory and the repeat values were believed to be correct.Refer to the attachment for all patient data.The serial number of the c 501 analyzer was (b)(4).
|