Catalog Number 08828610190 |
Device Problems
Incorrect Measurement (1383); Low Test Results (2458)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information for the investigation was requested but was not provided.The investigation did not identify a product problem.The cause of the event could not be determined.
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Event Description
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The initial reporter received questionable elecsys total psa immunoassay and elecsys free psa immunoassay results from 1 patient on a roche immunoassay analyzer.The initial total psa result was 9.78 ng/ml and the first repeat result was 9.73 ng/ml.The initial free psa result was 12.9 ng/ml and the first repeat result was 13.5 ng/ml.A dilution was performed and the second repeat total psa result was 9.56 ng/ml and the second repeat free psa result was 13.6 ng/ml.It is unclear if these results were from a separate sample.It is unknown if any results were reported outside of the laboratory.The analyzer model and serial number were requested but not provided.This medwatch will cover free psa.Refer to the medwatch with patient identifier (b)(6)for information on the total psa results.
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Manufacturer Narrative
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The sample was submitted for investigation.The total psa result was 5.88 ng/ml and the free psa result was 5.58 ng/ml.Gel filtration testing was also performed and the results showed that the amount of free psa in the patient sample was higher than the amount of total psa.The investigation is ongoing.
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Manufacturer Narrative
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The investigation found that there were no abnormal amounts of igg or igm detected in the sample.The investigation determined the issue is consistent with a rare psa-isoform that cannot be completely detected by the usage of standard total psa elecsys assay.The impact of the rare psa isoform on the elecsys results is also mentioned in the method sheet for total psa.Product labeling states, "it is known that in rare cases psa isoforms do exist which may be measured differently by different psa tests.Findings of this kind have occasionally been reported for psa tests from various manufacturers." there is no evidence that the elecsys free psa and total psa assays are disturbed by endogenous interfering substances.The original free psa measured value is considered to be correct.The investigation did not identify a product problem.Based on the available data, a general reagent issue could be excluded.
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Search Alerts/Recalls
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