The calibration and qc data at the investigation site were acceptable.Assays from different manufacturers can generate different results.This relates to the overall setups of the assays, the antibodies used, differences in reference materials, and the standardization methodology used.A general reagent issue can be excluded.The investigation did not identify a product problem.
|
The initial reporter questioned the results for 3 patient samples tested for elecsys ft4 iii (ft4 iii), elecsys tsh (tsh), and elecsys ft3 iii (ft3 iii) on a cobas e801 module.The samples were submitted for investigation where discrepant results were identified for ft4 iii and tsh between the customer¿s e801 module, an e801 module used at the investigation site, a cobas e 411 immunoassay analyzer used at the investigation site, and the abbott architect method.This medwatch will cover ft4 iii.Refer to medwatch with a1 patient identifier pt-75056 for information on the tsh results.Refer to the attached data for the patient results.It is not known if the questionable results from the customer¿s e801 module were reported outside of the laboratory.The customer¿s e801 module was 1752-03.The e801 module serial number used at the investigation site was 14d9-06.The e411 analyzer serial number was (b)(4).The ft4 iii reagent lot number used with the e801 module at the investigation was 600151with an expiration date of 30-jan-2023.The ft4 iii reagent lot number used with the e411 analyzer was 593219 with an expiration date of 31-dec-2022.
|