Catalog Number 08791686160 |
Device Problems
Incorrect Measurement (1383); Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/24/2023 |
Event Type
malfunction
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Event Description
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The initial reporter questioned the results for 3 patients tested for elecsys total psa (total psa) that did not correspond to their clinical history on a cobas e 411 immunoassay analyzer.On (b)(6) 2023 patient 1 result was 1.3 ng/ml.On (b)(6) 2023 a new sample was obtained and the result was 229 ng/ml.On (b)(6) 2023 patient 2 result was less than 0.01 ng/ml.On (b)(6) 2023 a new sample was obtained and the result was 4.69 ng/ml.On (b)(6) 2023 patient 3 result was 0.02 ng/ml.On (b)(6) 2023 a new sample was obtained and the result was 32.2 ng/ml.
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Manufacturer Narrative
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The e411 analyzer serial number was (b)(4).
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Manufacturer Narrative
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The medical device problem code was updated.The customer replaced the reagent pack and made a new calibrator.Calibration and qc passed.The field service engineer (fse) visited the customer site and confirmed the issue was resolved after the customer replaced the reagent pack and made a new calibrator.
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Search Alerts/Recalls
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