COMBUR 10 UX 100

Additional Manufacturer Narrative

CLARIFICATION WAS RECEIVED THAT THE CUSTOMER STATED THE DEVICE GAVE A RESULT THAT DID NOT MATCH THE VISUAL READING OF THE STRIP. THE TEST STRIP LOT NUMBER WAS 35703304.

Additional Manufacturer Narrative

BRAND NAME, COMMON DEVICE NAME WERE CORRECTED. MFR SITE AND PMA/510K WERE CORRECTED. THE URISYS 1100 ANALYZER SERIAL NUMBER WAS (B)(4). DURING INTERNAL TESTING, ROCHE DETERMINED THE LIMITS OF DETECTION (LOD) FOR PROTEIN, NITRITE, LEUKOCYTES, AND ERYTHROCYTES ON THE URISYS 1100 URINE ANALYZER WITH CHEMSTRIP® 5 OB, CHEMSTRIP 7, CHEMSTRIP 10 MD, AND CHEMSTRIP 10 UA TEST STRIPS WERE HIGHER THAN WHAT IS LISTED IN THEIR RESPECTIVE TEST STRIP METHOD SHEETS. THIS CAN LEAD TO FALSE NEGATIVE RESULTS ON THE URYSIS 1100 URINE ANALYZER FOR THE FOUR AFFECTED PARAMETERS. ROCHE HAS PROVIDED CUSTOMERS WITH THE FOLLOWING INSTRUCTIONS AND WORKAROUNDS: CHEMSTRIP 5 OB AND CHEMSTRIP 7 TEST STRIPS SHOULD ONLY BE READ VISUALLY. THEY CAN NO LONGER BE READ ON THE URISYS 1100 URINE ANALYZER. CHEMSTRIP 10 MD OR CHEMSTRIP 10 UA TEST STRIPS CAN BE USED WITH THE URISYS 1100 URINE ANALYZER; HOWEVER, A NEGATIVE RESULT FOR ANY ONE OF THE FOUR AFFECTED PARAMETERS (I.E., PROTEIN, NITRITE, LEUKOCYTES, AND ERYTHROCYTES) ON THE URISYS 1100 URINE ANALYZER MUST BE REPEATED WITH A NEW TEST STRIP THAT IS READ VISUALLY.

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF FALSE NEGATIVE RESULTS FOR 3 PATIENTS TESTED FOR NITRITES ON A URISYS 1100 ANALYZER. THE RESULTS WERE ALL "NEGATIVE" ON THE ANALYZER. IT IS NOT KNOWN IF THE RESULTS WERE DISCREPANT TO A VISUAL READING OF THE STRIP OR TO ANOTHER METHOD. THE COMPARISON METHOD WAS REQUESTED BUT HAS NOT BEEN PROVIDED. IT IS NOT KNOWN IF THE INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE TEST STRIP LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT WERE NOT PROVIDED.