Model Number U411 |
Device Problem
False Positive Result (1227)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The analyzer was cleaned in all areas, including the measurement area.The reference strip was changed.A new calibration was performed.After these actions, the patient and quality control results recovered correctly.This event occurred in (b)(6).
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Event Description
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The initial reporter stated they have received false positive nitrite results for an unspecified number of patient samples tested with combur 10 m test strips on a cobas u 411 analyzer.The affected patient samples will have positive nitrite results when tested on the u 411 analyzer, but the microscopic examination results do not agree with the positive nitrite values.The issue also occurs with quality control material.The combur m 10 test strip lot number was 41516505, with an expiration date of 31-jul-2020.
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Manufacturer Narrative
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The retention material of lot 415165 was measured on a retention cobas u411 and by visual reading with native urine and a nitrite dilution series.The results are comparable.
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Search Alerts/Recalls
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