The investigation could not identify a product problem.The cause of the event could not be determined.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.This event occurred in (b)(6).(b)(4).
|
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys ft4 iii assay on a cobas 8000 e 801 module and a second e 801 analyzer used for investigation.The values measured at the customer site were reported outside of the laboratory to a physician.Refer to the attachment for all patient data.The sample was initially tested on the customer's e 801 analyzer on (b)(6) 2020.The sample was repeated on a centaur analyzer.The sample was also provided for investigation, where it was tested on a second e 801 analyzer on (b)(6) 2020.The serial number of the customer's e 801 analyzer was requested, but not provided.The serial number of the e 801 analyzer used for investigation is (b)(4).Ft4 reagent lot number 432844, with an expiration date of september 2020 was used on this analyzer.
|