Catalog Number 09043276190 |
Device Problem
Low Test Results (2458)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/26/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The tsh and ferritin tests were performed on e602 module serial number (b)(6).The ft4 iv test was performed on e602 module serial number (b)(6).Qc was acceptable.The investigation is ongoing.
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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 iv (ft4 iv), elecsys ferritin (ferritin), and elecsys tsh (tsh) on 2 cobas 8000 e 602 modules.This medwatch will cover ft4 iv.Refer to medwatch with a1 patient identifier (b)(6) for information on the ferritin results and medwatch with a1 patient identifier (b)(6) for information on the tsh results.The initial tsh result was 0.029 uiu/ml.The repeat result was 2.90 uiu/ml.The initial ft4 iv result was 0.039 ng/dl.The repeat result was 1.26 ng/dl.The initial ferritin result was 1.01 ng/ml.The repeat result was 35.94 ng/ml.
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Manufacturer Narrative
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The repeat results were believed to be correct.Calibration data was acceptable.Based on the calibration and qc data, a general reagent issue can be excluded.The specific cause of the event could not be determined.The investigation determined the event was consistent with a pre-analytical handling issue.
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Search Alerts/Recalls
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