The customer reported that they received erroneous results for one patient sample tested for free triiodothyronine (ft3) and free thyroxine (ft4) on an e601 analyzer.This medwatch will cover ft4.Please refer to the medwatch with patient identifier (b)(6) for information referring to ft3.The sample, from (b)(6) 2016, was initially tested at the customer site on an e601 analyzer.The sample was provided for investigations.During investigations, the patient sample was tested on a modular pe analyzer and an e411 analyzer.Refer to the attachment for the specific patient result values.It was asked, but it is unknown if any erroneous patient results were reported outside of the laboratory.The patient was not adversely affected.The e601 analyzer serial number used at the customer site was asked for, but not provided.The modular pe analyzer used for investigation purposes was serial number (b)(4).The ft4 reagent lot number used on this analyzer was 125827, with an expiration date of january 2017.The e411 analyzer used for investigation purposes was serial number (b)(4).The ft4 reagent lot number used on this analyzer was 188609, with an expiration date of october 2016.
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