Catalog Number 09289275190 |
Device Problems
High Test Results (2457); Non Reproducible Results (4029)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred in (b)(6).Unique identifier (udi) #: (b)(4).Some calibration signals were below the expected range.Samples with larger volumes, showed good reproducibility when re-run.The customer¿s qc results were acceptable.A general reagent issue can be excluded.Based on the data provided, the investigation did not identify a product problem.The cause of the event could not be determined.
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Event Description
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The initial reporter repeated approximately 2,000 research patient samples from (b)(6) 2019 tested for elecsys anti-sars-cov-2 s (anti-sars-cov-2 s) on a cobas e801 module and the results for 7 patient samples were discrepant.The initial results from (b)(6) 2019 were positive; upon repeating the patient samples, the results for 7 patient samples were negative.The customer stated the volume was low on these samples.No questionable results were reported outside of the laboratory.It is not known if pcr testing was performed.No pcr test results have been provided.The e801 module serial number was (b)(4).
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Search Alerts/Recalls
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