Catalog Number 03271749160 |
Device Problems
High Test Results (2457); Insufficient Information (3190); Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/20/2023 |
Event Type
malfunction
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Event Description
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We received an allegation about discrepant results for 1 patient's serum sample tested with elecsys hcg+beta (hcg+b) assay on a cobas e411 immunoassay analyzer.Initial result: 225 miu/ml.The physician questioned the result as it did not match the patient's clinical condition (in the first few weeks of pregnancy).The sample was then repeated.Repeat result: 30 miu/ml.The repeat result was deemed to be correct.
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Manufacturer Narrative
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The hcg+b reagent expiration date was not provided.The cobas e411 disk serial number was (b)(6).Performance testing was done on 25-sep-2023 and 28-nov-2023 and the instrument was performing within specifications.The investigation is ongoing.
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Manufacturer Narrative
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Calibration and qc were requested but not provided.The customer confirmed that the sample sat for 30 minutes prior to the centrifugation.The alarm trace was requested but not provided.The field service engineer (fse) found no cause for the issue.The fse did a performance check and the instrument was performing within specifications.He did multiple checks including a system volume check, liquid flow cleaning history check, probe position, and wash check and they all passed.The laboratory's humidity was 23% at the time of the service visit.Qc was performed and it was within range.The investigation did not identify a product problem.The cause of the event could not be determined.
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Search Alerts/Recalls
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