CHEMSTRIP ® 10 UA

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF FALSE NEGATIVE RESULTS FOR 1 PATIENT USING CHEMSTRIP 10 UA TEST STRIPS ON A URISYS 1100 URINE ANALYZER. THE PATIENT HAD BEEN IN THE HOSPITAL PREVIOUSLY AND HAD A CATHETER. THE PATIENT HAD BEEN DISCHARGED BUT RETURNED WITH URINATION URGENCY ISSUES. THE PATIENT TESTED NEGATIVE FOR ALL PARAMETERS OF THE TEST STRIP. THE CUSTOMER SENT OUT A CONFIRMATION CULTURE. THE CONFIRMATION CULTURE RESULTS WERE AROUND 100,000 CFU. LEUKOCYTES WERE 5000. THE CUSTOMER BELIEVED THE PATIENT HAD SOME SORT OF INFECTION. THE PATIENT'S URINE WAS SENT FOR ANOTHER CULTURE ON (B)(6) 2019. THE URINALYSIS RETURNED AS POSITIVE FOR LEUKOCYTES AND ERYTHROCYTES AND THE NITRITES WERE NEGATIVE. THE CUSTOMER RECEIVED THE FINAL REPORT ON (B)(6) 2019 AND THE REPORT INDICATED E-COLI WAS GROWING (100,000 CFU-ML). AFTER THE FINAL REPORT WAS RECEIVED, THE PATIENT WAS DIAGNOSED WITH A URINARY TRACT INFECTION. TREATMENT FOR THE INFECTION WAS DELAYED BETWEEN (B)(6) 2019. THE SPECIFIC TREATMENT PROVIDED IS NOT KNOWN. AN ADVERSE EVENT DID NOT OCCUR DUE TO DELAYING THE TREATMENT BY 2 DAYS. THE METER AND TEST STRIPS WERE REQUESTED FOR INVESTIGATION.

Additional Manufacturer Narrative

THE CUSTOMER RETURNED THE METER (SERIAL NUMBER (B)(6)). THE LIMITS OF DETECTION (LOD) ISSUE HAS SINCE BEEN RESOLVED WITH A METER SOFTWARE VERSION UPDATE.

Additional Manufacturer Narrative

RETENTION MATERIAL FOR STRIP LOT 33828901 WAS MEASURED WITH 0-NATIVE-URINE AND A NITRITE-DILUTION-SERIES AND VISUALLY CHECKED. THE RESULTS OF THE MEASUREMENTS FOR ALL RETENTION AND CUSTOMER MATERIALS FULFILL OUR REQUIREMENTS. NO FALSE NEGATIVE RESULTS WERE OBSERVED.

Additional Manufacturer Narrative

THE CUSTOMER METER WAS REQUESTED BUT NOT RETURNED. ONE VIAL OF LOT 29191102 "CHEMSTRIP 10 UA 100 STR.", CONTAINING 87 OF 100 TEST STRIPS WAS RETURNED. 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.