The initial reporter received questionable elecsys ft4 iii assay results for one patient tested on a cobas 8000 e 801 module and a cobas e411 rack.The customer reported no issues with qc.It is unknown if the elecsys ft4 results were reported outside the laboratory, the information was requested but not provided.The customer sent the patient's sample for investigation and the patient's sample was tested on a cobas 8000 e 801 module and a cobas e 411 immunoassay analyzer.Also, the patient's sample was outsourced and tested on an abbott architect analyzer.The e411 rack serial number was (b)(4).The e 801 module serial number was (b)(4).This medwatch is for ft4 assay on the cobas e411 rack.Refer to the medwatch with patient identifier (b)(6) for the ft3 assay on the e 801 module.
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This medwatch is for ft4 assay on the cobas e411 rack.Refer to the medwatch with a1 patient identifier (b)(6) for the ft4 assay on the e 801 module.The customer's calibration, qc, system alarm trace, and sample pre-analytical information were requested but not provided.The patient's ft4 result tested on the customer's cobas e411 rack could not be reproduced at the investigation's site.The patient's sample was not available for further testing due to not enough sample volume remained.From the information provided, a general reagent issue could be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.
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