The customer reported that they received questionable results for one patient sample tested for thyrotropin (tsh), free triiodothyronine (ft3), and free thyroxine (ft4).Of the three tests, the sample had erroneous results for ft3 and ft4.It was asked, but the date of the event is not known.This medwatch will cover ft4.Refer to the medwatch with a1.Patient identifier (b)(6) for information referring to ft3.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.Refer to the attachment for the specific patient result values.It was asked, but it is unknown 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 183473, with an expiration date of january 2016.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.
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