Catalog Number 08791686190 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/10/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The calibration performed on (b)(6) 2023 had signals within the expected range.The calibration performed on (b)(6) 2023 had signals below the expected range for calibrator level 2.Quality controls were acceptable.Instrument performance testing was acceptable.The investigation is ongoing.H3 other text : na.
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Event Description
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The initial reporter stated they received questionable results for one patient tested with the elecsys free psa and the elecsys total psa assay on a cobas e411 analyzer.The free psa values were greater than the total psa values.The questionable results were not reported outside of the laboratory.This medwatch will apply to the total psa assay.Please refer to the medwatch with a1.Patient identifier pt-81609 for information related to the free psa assay.A first sample of the patient was tested on (b)(6) 2023: the first sample initially resulted in a free psa value of 1.46 ng/ml.The first sample initially resulted in a total psa value of 0.066 ng/ml.A second sample of the patient was tested on (b)(6) 2023: the second sample initially resulted in a free psa value of 1.58 ng/ml.The second sample initially resulted in a total psa value of 0.061 ng/ml.A third sample of the patient was tested on (b)(6) 2023 in a different laboratory using the siemens method: the third sample initially resulted in a free psa value of 0.03 ng/ml.The third sample initially resulted in a total psa value of 1.21 ng/ml.The results obtained with the siemens method are considered correct.The serial number of the e411 analyzer is (b)(6).
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Manufacturer Narrative
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The patient sample was requested for investigation but could not be provided.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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