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 12/27/2023 |
Event Type
malfunction
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Event Description
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We received an allegation about discrepant results for 1 patient's serum/plasma sample tested with elecsys ferritin (ferr) assay on a cobas pure e402 analytical unit.Initial result: 1.69 ng/ml.No questionable result was reported outside the laboratory as the customer noticed that the result did not match the patient's previous results.The sample was then repeated.Repeat result: 49.0 ng/ml.
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Manufacturer Narrative
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The ferr reagent expiration date was not provided.The cobas pure e402 analytical unit serial number was (b)(6).Qc was within the ranges.The investigation is ongoing.
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Manufacturer Narrative
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A general reagent problem can be excluded because the qc prior to the event was within ranges.The alarm trace did not show any abnormality.The provided pre-analytical information did not show any abnormality.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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