Catalog Number 07976887190 |
Device Problems
Incorrect Measurement (1383); High Test Results (2457); Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/27/2024 |
Event Type
malfunction
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Manufacturer Narrative
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The serial number of the e 801 analyzer was (b)(6).Quality controls were acceptable.The investigation is ongoing.
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Event Description
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The initial reporter stated they received questionable results for patient samples tested with elecsys ft4 iii on a cobas e 801 analytical unit.When switching to a new reagent pack, the first few samples recovered values above the measuring range of the assay.When repeated, these samples recovered normal values.The customer provided an example of one patient sample with discrepant ft4 results.No questionable results were reported outside of the laboratory.This sample initially resulted in an ft4 value of > 100.00 pmol/l with a data flag.This value did not match the patient's clinical diagnosis.The sample was repeated, resulting in an ft4 value of 19.50 pmol/l.
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Manufacturer Narrative
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A general reagent issue can be ruled out because the qc prior to the event was within ranges and afterwards, the reagent worked as intended.Isolated non-reproducible results do not represent a general malfunction of the assay.The investigation could 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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