Catalog Number 08791686160 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/09/2023 |
Event Type
malfunction
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Event Description
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The initial reporter received a questionable elecsys total psa (total psa) result from one patient sample tested on the cobas e411 rack.The initial result was reported to the physician.The physician questioned the result as it was not reflective of the patient's condition.The initial result from the analyzer was 0.06 ng/ml.The first repeat result from the analyzer was 4.2 ng/ml.This repeat result was deemed correct. the second repeat result from their other e 411 was 4.5 ng/ml.
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Manufacturer Narrative
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The reagent lot number is 708242.The expiration date was requested but not provided.The field service engineer inspected the analyzer and was not able to establish a cause for the event.He then verified the proper mechanical alignments and performed service testing with successful results.The investigation is ongoing.
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Manufacturer Narrative
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The investigation reviewed the last calibration performed on 03-nov-2023.The calibration signal 1 was within specifications; calibration signal 2 was slightly lower than expected.The investigation reviewed the qc recovery; the recovery was within -2 standard deviations (sd); the results were within specifications.There is no indication of a performance issue with the reagent or analyzer.The investigation reviewed the alarm trace; the trace had no conspicuous alarms but the cumulative alarm trace had an "assay reagent vol.Inadequate" alarm.Based on the information provided, the cause of the event could not be determined.The investigation did not identify a product problem.
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Search Alerts/Recalls
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