CHEMSTRIP ® 10 MD

Additional Manufacturer Narrative

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. IN THIS CASE, THE CUSTOMER RETURNED THE METER AND TEST STRIPS. THE TEST STRIPS SHOWED NO ABNORMALITIES AND THE METER WAS CLEAN AND SHOWED NO DAMAGE. THE RETENTION MATERIAL OF LOT 36255000 WAS MEASURED ON A URISYS 1800/U411 AT THE INVESTIGATION SITE WITH 0-NATIVE URINE AND AN ERYTHROCYTES-DILUTION-SERIES AND WAS VISUALLY CHECKED ACCORDING TO THE TESTING-PLAN. THE RESULTS OF THE MEASUREMENTS FULFILL OUR REQUIREMENTS. IN THIS CASE, NEITHER FALSE POSITIVE NOR FALSE NEGATIVE RESULTS WERE OBSERVED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THIS EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

QC WAS NOT PERFORMED ON THE METER, ONLY CALIBRATION. THE METER AND TEST STRIPS WERE REQUESTED FOR INVESTIGATION.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF A NEGATIVE ERYTHROCYTES RESULT FOR 1 PATIENT TESTED WITH CHEMSTRIP 10 MD URINE TEST STRIPS ON A URISYS 1100 ANALYZER WITH SERIAL NUMBER (B)(4). THE PATIENT HAD A NEGATIVE RESULT WHEN TESTED ON THE ANALYZER. A VISUAL TEST WAS PERFORMED IMMEDIATELY WITH A FRESH SAMPLE AND THE RESULT WAS APPROXIMATELY 250 ERYTHROCYTES/MICRO LITER. NO CHANGES WERE MADE TO THE PATIENT'S MEDICATION BASED ON THE NEGATIVE RESULT. THE RESULT FROM THE VISUAL TEST WAS BELIEVED TO BE CORRECT. NO OTHER TESTS WERE PERFORMED. NO ADVERSE EVENT OCCURRED.