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Model Number FT4 G3 |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation could not identify a product problem.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.
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Event Description
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The initial reporter stated they received discrepant results for 8 patient samples tested with the elecsys tsh and the elecsys ft4 iii assay on multiple roche analyzers and compared to the abbott architect method.The questionable results were reported outside of the laboratory.This medwatch will apply to the ft4 iii assay.Please refer to the medwatch with a1.Patient identifier (b)(4) for information related to the tsh assay.The samples were initially tested with tsh and ft4 iii on the customer's cobas e 801 module on an unknown date.The samples were provided for investigation, where they were tested with the tsh and ft4 iii assays on a second e 801 module on (b)(6) 2023.During investigations, the samples were also tested with the tsh and ft4 iii assays on a cobas e 411 analyzer on (b)(6) 2023.The samples were also repeated using the abbott architect tsh and ft4 methods on (b)(6) 2023.Refer to the attachment for all relevant test data.The serial number of the customer's e 801 analyzer was requested but not provided.The serial number of the e 801 analyzer used for investigation is 14d9-06.Ft4 iii reagent lot number 630888, with an expiration date of 31-may-2023 was used on this analyzer.The serial number of the e411 analyzer used for investigation is 65g1-25.Ft4 iii reagent lot number 623234, with an expiration date of 30-apr-2023 was used on this analyzer.
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Search Alerts/Recalls
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