The customer reported that they received erroneous results for one patient sample tested for thyrotropin (tsh), free triiodothyronine (ft3), and free thyroxine (ft4).It was asked, but the date the event occurred is not known.This medwatch will cover ft4.Refer to the medwatch with patient identifier (b)(6) for information referring to ft3.Refer to the medwatch with patient identifier (b)(6) for information referring to tsh.The sample was initially tested at the customer site on an e602 analyzer and then repeated on a centaur analyzer.During investigations, the patient sample was tested on an e170 analyzer and an e411 analyzer on (b)(6) 2015.Refer to the attachment for the specific patient result values.It was asked, but it is not known which patient results, if any, were reported outside of the laboratory.It was asked, but it is not known if the patient was adversely affected.No adverse events were alleged.The e602 analyzer serial number used at the customer site was asked for, but not provided.The e170 analyzer used for investigation purposes was serial number (b)(4).The ft4 reagent lot number used on this analyzer was 180539, with an expiration date of october 2015.The e411 analyzer used for investigation purposes was serial number (b)(4).The ft4 reagent lot number used on this analyzer was 180539, with an expiration date of october 2015.A specific root cause could not be determined as there was no remaining sample available for further investigations.Based on the provided information, a general reagent issue can most likely be excluded.When comparing values generated by different types of analyzers, variances can be expected.For thyroid parameters, age, gender, and other characteristics are to be considered when analyzer measured values.
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