Catalog Number 08454345001 |
Device Problems
Low Test Results (2458); Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/02/2023 |
Event Type
malfunction
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Event Description
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The initial reporter stated they received discrepant results for one patient sample tested with elecsys prolactin ii on a cobas e 801 analytical unit.The sample initially resulted in a prolactin value of 870 uiu/ml.The sample was treated with polyethylene glycol (peg) and repeated.The result was higher than the initial value.No specific value was provided.Since the peg treated value was higher, the sample was repeated two additional times on (b)(6) 2023, resulting in prolactin values of 1430 uiu/ml and 1416 uiu/ml.
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Manufacturer Narrative
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The serial number of the e801 analyzer is (b)(6).The investigation is ongoing.
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Manufacturer Narrative
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Calibration data was within expectations.Quality controls recovered within range.A reagent issue was not present since controls before the event were within range.Upon review of the alarm trace, no relevant alarms were observed.The field service engineer checked and cleaned dirty reagent probes, sipper nozzles, and pre-wash nozzles.The analyzer was often giving degasser low-pressure errors, so the degasser pump was replaced.The investigation determined the service actions resolved the issue.The operator is required to clean all probes and nozzles daily.
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Search Alerts/Recalls
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