Model Number COMBUR-10-M |
Device Problem
High Test Results (2457)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/29/2019 |
Event Type
malfunction
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Manufacturer Narrative
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After calibration, there were no more discrepancies with nitrite results.This event occurred in (b)(6).
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Event Description
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The initial reporter stated that they have received discrepant high results for an unspecified number patient samples tested for nitrites on a cobas u 411 analyzer.No incorrect results were reported outside of the laboratory.The reporter stated that they tested 142 urine samples per day over a 6 day period using the same test strip lot number.When testing the samples on the u 411 analyzer, the nitrite results will be positive.When running test strips manually on these samples, the visual reading is negative for nitrite.No adverse events were alleged to have occurred with the patients.The serial number of the u 411 analyzer is (b)(4).The reporter's product was requested for investigation.
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Manufacturer Narrative
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Expiration date was updated.The retention material, lot 37378000, was measured on investigation unit urisys 1800 and u 411 analyzer with 0-native urine and a nitrite-dilution-series and was visually checked.The results of the measurements fulfill the requirements.No false positive results were observed.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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