Catalog Number 08791732190 |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is ongoing.
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Event Description
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There was an allegation of a questionable elecsys total psa immunoassay result for two patients due to interference.Patient 1: the patient had a prostatectomy in 2014 (probably in december).On (b)(6) 2022, the initial result was 0.494 ng/ml and was reported outside of the laboratory.On (b)(6) 2022, the repeat result was 0.475 ng/ml.A separate sample collected on (b)(6) 2022 and repeated three times had a result of < 0.14 ng/ml.This was the expected result for the patient as the previous result for the patient in 2021 was < 0.14 ng/ml.Patient 2: the patient had a probable prostatectomy.The result from a sample in (b)(6) 2021 was < 0.014 ng/ml.The second sample collected in (b)(6) 2021 had a result of 0.446 ng/ml.The repeat result in (b)(6) 2022 was 0.360 ng/ml.The specific dates of testing were not provided.A third sample collected in (b)(6) 2022 had a result of <0.014 ng/ml.This was the expected result for the patient.The questionable results were reported outside of the laboratory.The customer used cobas e 801 module serial number (b)(4).
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Manufacturer Narrative
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As no sample material could be provided for further investigation, the cause of the event could not be determined.The investigation did not identify a product problem.Based on the data and information provided, a general reagent issue can be excluded.
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Search Alerts/Recalls
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