Catalog Number 08828610190 |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/28/2023 |
Event Type
malfunction
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Event Description
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The initial reporter questioned a result for 1 patient sample tested for elecsys free psa (free psa) on a cobas e 801 analytical unit.The free psa result was 0.49 ug/l.The total psa result from the e801 analyzer was 0.07 ug/l.On (b)(6)2023 the total psa result from a competitor method was <0.10 ug/l.The customer suspects an interference.
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Manufacturer Narrative
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The e801 analyzer serial number was (b)(6).The competitor method was the abbott architect.
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Manufacturer Narrative
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The sample was received for investigation.The customer's results were confirmed during the investigation.The sample was further investigated and no interference was identified for the free psa assay.An interference affecting the total psa assay was identified.Product labeling for total psa 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.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the presence of a seldom psa-isoform that cannot be completely detected by the usage of the standard total psa elecsys assay caused the low total psa result.The free psa result is considered to be correct.The investigation did not identify a product problem.
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Search Alerts/Recalls
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