The customer questioned results from 2 patient samples tested for thyrotropin (tsh), free thyroxine (ft4) and free triiodothyronine (ft3).The customer provided the samples for investigation.Of the data provided, erroneous ft4 results were identified between the customer's e602 analyzer, a centaur analyzer, an e 170 analyzer used at the investigation site and an e411 analyzer used at the investigation site.The date of tests performed at the customer site is not known.It is not known if erroneous results were reported outside of the laboratory.Refer to the attachment to the medwatch for patient results.No adverse event was reported.The e 170 analyzer serial number was (b)(4).The e411 analyzer serial number was (b)(4).The ft4 reagent lot number used at the investigation site was 180539 with an expiration date of 10/31/2015.The serial number for the customer's e602 analyzer is not known.A specific root cause could not be identified.Based on the available data, a general reagent issue could be excluded.When comparing values from different types of analyzers, variances can be expected.For thyroid parameters, age, gender and other patient characteristics should be considered when comparing values.
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