Model Number U1100 |
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 09/17/2019 |
Event Type
malfunction
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Manufacturer Narrative
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A new test strip tray was sent to the reporter and upon installation of this new test strip tray on the urisys 1100 analyzer, no further issues with nitrite results were observed.This event occurred in (b)(6).
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Event Description
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The initial reporter stated they have been receiving false positive nitrite results for an unspecified number of patient samples tested using urisys 1100 analyzer serial number (b)(4).The issue started occurring after the urisys 1100 software was updated to version 5.71.When an affected sample is run on a test strip on the urisys 1100 analyzer, the nitrite result will be positive.When visually reading the same test strip, no color change is visible on the nitrite test pad.The issue occurs with different patient urine samples.The lot number and expiration date of the test strips used on the analyzer were requested, but not provided.
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Manufacturer Narrative
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The customer's urisys 1100 analyzer was provided for investigation.The device was clean and did not show any damages.The customer's urisys 1100 analyzer, including the customer test strip tray, was measured with test strip lot #43065200 with native urine.Results: the retention material and the customer analyzer showed no false positive results and fulfilled requirements.Medwatch fields d10 and h3 have been updated.
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Search Alerts/Recalls
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