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.Unique identifier (udi) # (b)(4).This event occurred in (b)(6).
|
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys tsh assay, the elecsys tsh assay ver.2, and the elecsys ft4 iii assay on two cobas 8000 e 801 module analyzers.The results measured at the customer site were reported outside of the laboratory to a physician.This medwatch will apply to the ft4 assay.Please refer to the medwatch with patient identifier (b)(6) for information related to the tsh assay and refer to the medwatch with patient identifier (b)(6) for information related to the tsh v2 assay.Refer to the attachment for all patient data.The sample was initially tested on the customer's e 801 analyzer on (b)(6) 2021.The sample was repeated for tsh on the customer's e 801 analyzer after x2, x5, and x10 dilutions.The sample was also treated with a 25 % polyethylene glycol (peg) solution and repeated on the customer's e 801 analyzer.The sample was repeated using the wako accuraseed method and the abbott architect method.The sample was provided for investigation, where it was tested using a second e 801 analyzer on (b)(6) 2021.The serial number of the customer's e 801 analyzer is (b)(4).The ft4 reagent lot number and expiration date used on this analyzer was requested, but not provided.The serial number of the e 801 analyzer used for investigation is (b)(4).Ft4 reagent lot number 483198, with an expiration date of june 2021 was used on this analyzer.
|