CHEMSTRIP ® 10 MD

Additional Manufacturer Narrative

DEVICE REQUESTED FOR RETURN BUT WAS NOT AVAILABLE.

Description of Event or Problem

THE CUSTOMER COMPLAINED OF A FALSE NEGATIVE NITRITE RESULTS FOR 4 PATIENT URINE SAMPLES FROM URISYS 1100 URINE ANALYZER SERIAL NUMBER (B)(4). THE DATE OF THE EVENT WAS AN APPROXIMATION. THE CUSTOMER STATED THAT THERE WERE 4 PATIENTS BETWEEN THE TIME OF (B)(6) 2018 TO (B)(6) 2018 WHERE THE NITRITE RESULTS WERE NEGATIVE BUT SHOULD HAVE BEEN POSITIVE. THE POSITIVE RESULT WERE CONFIRMED VIA VISUAL INSPECTION. THE CUSTOMER NOTICED THAT THE TEST STRIPS APPEARED PINK INDICATING A POSITIVE RESULT WHILE THE METER SHOWED NEGATIVE RESULTS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE METER AND TEST STRIP HAVE BEEN REQUESTED FOR RETURN. THE TEST STRIPS WERE NOT AVAILABLE FOR RETURN. 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

CORRECTION REMOVAL REPORT NUMBER HAS BEEN UPDATED. 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.