Catalog Number ASKU |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/06/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The serial number of the e 801 analyzer is (b)(6).The investigation is ongoing.
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Event Description
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The initial reporter stated they received discrepant results for one patient sample tested with elecsys free psa and elecsys total psa on a cobas e 801 analytical unit.This medwatch will apply to the total psa assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for information related to the free psa assay.The sample resulted in free psa values of 0.205 ng/ml and 0.206 ng/ml when tested on the e 801 analyzer.The sample was tested on a second analyzer, resulting in a free psa value of 0.0747 ng/ml.The 0.0747 ng/ml value agreed with the patient's previous results.The sample resulted in a total psa value of 0.195 ng/ml when tested on the e801 analyzer.
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Manufacturer Narrative
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The investigation did not identify a product problem.The cause of the event could not be determined.The reagent performed within specifications and a general reagent-related issue could be excluded.
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Search Alerts/Recalls
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