The customer reported that they received erroneous results for two samples from the same patient samples tested for elecsys ft3 iii (ft3) and the elecsys ft4 ii assay (ft4) on an e170 analyzer.This medwatch will cover ft4.Patient identifier (b)(6) for information related to ft3.The first patient sample, dated (b)(6) 2016, was initially tested at the customer site on their e170 analyzer.During investigations, this sample was tested on a modular-pe analyzer and an e411 analyzer.The results obtained at the customer site for the second sample from the same patient (dated (b)(6) 2016) were not provided.During investigations, this second sample was also tested on the modular-pe analyzer and 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.The patient was not adversely affected.The e170 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 168540, with an expiration date of july 2017.A specific root cause could not be determined based on the provided information.There was not enough sample volume remaining for further investigation.A general reagent issue could not be detected.A biological component may be present in the sample that would interact differently with the assay components during the pre-wash procedure.The customer's e170 analyzer and the modular-pe analyzer use the pre-wash procedure.The e411 analyzer does not use the pre-wash procedure, so this may result in discrepant results when compared to the analyzers using the pre-wash procedure.
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