Model Number U1100 |
Device Problem
Low Test Results (2458)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 04/10/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
The customer received questionable nitrite and leukocyte results from the urisys 1100 urine analyzer serial number (b)(4) compared to the visual reading of the test strip.Of the data provided, only the results for nitrite were a reportable malfunction.The result from the analyzer was negative and the result from the visual exam within one minute was "trace".The patient was not treated based on the false negative result and was given antibiotics based on the visual reading.The patient was currently fine.There was no allegation of an adverse event.The test strip lot number was 26977405 with an expiration date of 31-jan-2019.The suspect meter and strips were requested to be returned for investigation.Replacement product was sent.
|
|
Manufacturer Narrative
|
Additional material was requested for the investigation but not provided.The investigation was unable to find a definitive root cause.
|
|
Manufacturer Narrative
|
The retention material of lot #269774 was tested on an iu urisys1100 with native urine and a nitrite-dilution-series and was visually checked.The results fulfilled the requirements and no false negative results were observed.
|
|
Search Alerts/Recalls
|