Catalog Number 09203095190 |
Device Problems
False Positive Result (1227); 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 11/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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This event occurred in (b)(6).The investigation determined the customer was not using the required rack adapters while using 13mm tubes and the customer did not perform level 2 qc.Product labeling states: "not using a roche rack cup adapter with 13 mm tubes or incorrect use of a roche rack cup adapter may cause incorrect results or errors.Always use roche rack cup adapters with 13mm tubes.".
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Event Description
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The initial reporter received questionable elecsys anti-sars-cov-2 results for 1 patient sample on a cobas e 411 immunoassay analyzer, serial number (b)(4).The initial result was coi 1.49 (positive).The repeated results were coi 0.192 and coi 0.732 (both negative).The results were not reported outside of the laboratory.
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Manufacturer Narrative
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The customer tested the sample a fourth time and the result was negative.A numerical value for this repeated result was not provided.The customer believed the correct result to be negative.Based on the provided data/information a general reagent issue can be excluded.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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