COMBUR-10-M 100 STR

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT NITRITE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH COMBUR 10 M TEST STRIPS ON A COBAS U 411 ANALYZER. THE REPORTER SUSPECTS THE UROBERRY MEDICATION THE PATIENT WAS TAKING INTERFERED WITH THE TEST METHOD. THE SAMPLE INITIALLY RESULTED WITH A POSITIVE NITRITE VALUE ACCOMPANIED BY A DATA FLAG WHEN TESTED ON THE U 411 ANALYZER. THE SAMPLE WAS REPEATED ON THE U 411 ANALYZER, RESULTING WITH A NEGATIVE NITRITE VALUE. THE SAMPLE WAS ALSO TESTED MANUALLY USING A COMPETITOR URINE TEST STRIP (SPINREACT) AND THE NITRITE RESULT WAS POSITIVE. THE U 411 ANALYZER SERIAL NUMBER IS (B)(4).

Additional Manufacturer Narrative

THE RETENTION MATERIAL OF LOT 41516500 WAS MEASURED ON A RETENTION COBAS U411 AND ALSO CHECKED BY VISUAL READING WITH NATIVE URINE AND A NITRITE DILUTION SERIES. THE RETENTION MATERIAL SHOWED NO FALSE POSITIVE RESULTS AND FULFILLED REQUIREMENTS.