This event occurred in (b)(6).All values, generated from all types of analyzers, were above the normal reference range for each respective assay.Calibration and qc 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.Based on the information provided, a general reagent issue can be excluded.The investigation did not identify a product problem.(b)(4).
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The initial reporter questioned thyroid results for 1 patient sample tested for elecsys tsh (tsh), elecsys ft4 iii (ft4 ii), and elecsys ft3 iii (ft3 iii) on a cobas e 801 module compared to the accuraseed method.The patient sample was submitted for investigation where discrepant results were identified for ft4 iii between the customer's e801 module, the architect method and an e801 module used at the investigation site.The initial results from the customer site were reported outside of the laboratory.Refer to attached data for the patient results.The customer's e801 module serial number was (b)(4).The e801 module serial number used at the investigation site was (b)(4).The ft4 iii reagent lot number used at the investigation site was 432844 with an expiration date of sep-2020.
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