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 06/02/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The patient's sample was requested for investigation.The investigation is ongoing.
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Event Description
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The initial reporter stated they received questionable results for two samples collected from the same patient and tested with the elecsys total psa ver.2 immunoassay on a cobas 8000 e 801 module.No incorrect results were reported outside of the laboratory.The first sample collected from the patient resulted in a total psa value of 13.1 ug/l when tested on the e 801 analyzer.The sample was sent to other laboratories for repeat testing on a siemens attelica im1300 and a beckman coulter unicel dx1800.The result from the siemens analyzer was 0.2 ug/l and the result from the beckman analyzer was 0.095 ug/l.The second sample collected from the patient resulted in a total psa value of 11.1 ug/l when tested on the e 801 analyzer on (b)(6) 2021.The sample was sent to other laboratories for repeat testing on a siemens attelica im1300 and a beckman coulter unicel dx1800.The result from the siemens analyzer was 0.15 ug/l and the result from the beckman analyzer was 0.115 ug/l.The patient samples were checked for heterophile antibody interference with the roche and siemens methods and there were no differences in respective values.The serial number of the e 801 analyzer was requested, but not provided.
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Manufacturer Narrative
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A third sample collected from the same patient also had a discrepancy in psa results.This sample initially resulted in a psa value of 16.30 ug/l when tested on the e 801 analyzer on (b)(6)-2021.The sample was repeated on an advia centaur xpt analyzer, resulting in a psa value of 0.27 ug/l.Medwatch field b3.Has been updated.
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Manufacturer Narrative
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A sample from the patient, dated (b)(6)2021 was provided for investigation.Upon initial investigation of the sample, it was tested with the total psa reagent on an e801 resulting in a value of 7.89 ng/ml and on a cobas e 411 immunoassay analyzer resulting in a value of 8.50 ng/ml.The investigation is ongoing.
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Manufacturer Narrative
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Investigation of the submitted patient sample determined there was an interfering substance in the sample.These interference are documented in product labeling for the assay: in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.
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Search Alerts/Recalls
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