COMBUR 10 UX 100

Additional Manufacturer Narrative

THE CUSTOMER'S CALIBRATION AND QC RESULTS WERE ACCEPTABLE. THE RETENTION MATERIAL OF LOT 415165 WAS MEASURED ON AN IU COBAS U411 / URISYS 1800 WITH 0-NATIVE-URINE AND A NITRITE-DILUTION-SERIES AND WAS VISUALLY CHECKED. THE MEASUREMENTS SHOWED NO FALSE-POSITIVE RESULTS AND SHOWED NO ABNORMALITIES. THE INVESTIGATION IS CURRENTLY ONGOING. THE EVENT OCCURRED IN: (B)(6).

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF FALSE-POSITIVE NITRITE RESULTS FOR TWO PATIENTS TESTED ON A URISYS 1100 ANALYZER SERIAL NUMBER (B)(4) USING COMBUR 10 UX TEST STRIPS. THE CUSTOMER STATED THAT THE POSITIVE NITRITE RESULTS WERE NOT MATCHING THE PATIENT'S CLINICAL PICTURES AS BOTH PATIENTS HAD NO SIGNS OF URINARY TRACT INFECTIONS. THE INITIAL NITRITE RESULTS FOR BOTH PATIENTS WERE POSITIVE. UPON REPEAT TESTING THE NITRITE RESULTS FOR BOTH PATIENTS WERE NEGATIVE. THE RESULTS IN QUESTION WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

Additional Manufacturer Narrative

THE CUSTOMER PROVIDED THE REQUESTED MATERIALS FOR AN INVESTIGATION. THE CUSTOMER MATERIAL OF LOT 41516501 WAS MEASURED ON A COBAS U411 / URISYS 1800 WITH NATIVE URINE AND A NITRITE DILUTION-SERIES. THE CUSTOMER MATERIAL SHOWED NO FALSE POSITIVE RESULTS AND FULFILLED THE REQUIREMENTS. ADDITIONALLY, THE CUSTOMER URISYS 1100 ANALYZER UX09630726 WAS MEASURED WITH ANOTHER STRIP LOT #43065200 WITH NATIVE URINE. QUALITY CONTROL TESTS USING RANDOX URNAL 1 NEGATIVE, AND 2 POSITIVE, WERE PERFORMED IN DUPLICATE, WHICH GAVE EXACTLY THE SAME EXPECTED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.