Catalog Number 07027273190 |
Device Problems
Low Test Results (2458); Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/08/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The qcs were in range.The level 1 calibration and level 2 calibration results were slightly below the approximate expected range.The investigation is ongoing.
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Event Description
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The initial reporter received a questionable elecsys ferritin (ferritin) result from one patient sample tested on the cobas e 801 analytical unit with serial number 20x6-04.The initial result was reported to the medical personnel and was rejected as it did not fit the medical state and the previous results of the patient.The initial result of the undiluted sample was 64.5 ng/ml.The first repeat result of the undiluted sample was 2000 ng/ml with a data flag.The second repeat result using a diluted sample was 4370 ng/ml.This repeat result was deemed correct as it is in line with the previous results and the clinical picture.
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Manufacturer Narrative
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The most observed alarm in the alarm trace was "reagent probe liquid-level detection (lld)".This suggests a pre-analytic reagent handling issue.A general reagent issue was not identified.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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