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 03/29/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred in (b)(6).Unique identifier (udi): (b)(4).The sample was requested for further investigation.
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Event Description
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The initial reporter complained of discrepant results for 1 patient sample tested for elecsys ft3 iii (ft3 iii) on a cobas e801 module compared to the accuraseed analyzer.The results from the e801 module were reported outside of the laboratory where the physician requested additional testing.The sample was submitted for investigation where discrepant results were identified for ft3 iii and elecsys ft4 iii (ft4 iii) between the customer¿s e801 module, the abbott architect method and an e801 module used at the investigation site.This medwatch will cover ft4 iii.Refer to medwatch with patient identifier (b)(4) for information on the ft3 iii results.The customer¿s e801 serial number was (b)(4).The e801 serial number used at the investigation site was (b)(4).The ft4 iii reagent lot number used at the investigation site was 483198 with an expiration date of jun-2021.
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Manufacturer Narrative
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The sample was received for investigation.The sample was tested on an e801 module with an ft4 result of 1.46 ng/dl (within the reference range).The difference in the ft4 results are due to the overall setups of the assays, the antibodies used, differences in reference materials and the standardization methodology used.The investigation did not identify a product problem.
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Search Alerts/Recalls
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