Model Number TSH |
Device Problem
High Test Results (2457)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/12/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred in (b)(6).
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Event Description
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The initial reporter complained of discrepant results for 1 patient sample tested for elecsys ft4 iii (ft4 iii), elecsys tsh (tsh) and elecsys ft3 iii (ft3 iii) on a cobas e801 module compared to the lumipulse method.This medwatch will cover tsh.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results and medwatch with patient identifier (b)(6) for information on the ft4 iii results.The ft4 iii result from the e801 module was > 7.77 ng/dl.The repeat from the lumipulse method was 1.18 ng/dl.The tsh result from the e801 module was 2.03 uiu/ml.The repeat from the lumipulse method was 1.39 uiu/ml.The ft3 iii result from the e801 module was 6.67 pg/ml.The repeat from the lumipulse method was 3.33 pg/ml.The erroneous results were reported outside of the laboratory.There was no allegation that an adverse event occurred.The e801 module serial number was (b)(4).
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Manufacturer Narrative
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The sample was tested at the investigation site using e801 module serial number (b)(4): the ft4 iii result was 1.38 ng/dl with reagent lot 380330 expiring dec-2019.The tsh result was 66.9 uiu/ml with reagent lot 331814 expiring aug-2019.The ft3 iii result was 8.62 pg/ml with reagent lot 348359 expiring oct-2019.Was updated.
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Manufacturer Narrative
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No sample material could be provided for further investigation.From the data provided, a general reagent issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.
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Search Alerts/Recalls
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