CHEMSTRIP ® 10 MD

Additional Manufacturer Narrative

THE CUSTOMER HAS DISCARDED THE TEST STRIPS.

Description of Event or Problem

THE CUSTOMER COMPLAINED OF FALSE NEGATIVE RESULTS ON ALL PARAMETERS FOR 2 PATIENTS TESTED WITH CHEMSTRIP 10 MD URINE TEST STRIPS ON URISYS 1100 URINE ANALYZER WITH SERIAL NUMBER (B)(4). PATIENT 1 RESULTS WERE NEGATIVE FOR ALL PARAMETERS. THE PATIENT'S CULTURE CAME BACK AS GREATER THAN 100,000 CFU/ML E COLI ON (B)(6) 2019. WHEN THE CULTURE WAS RECEIVED, THE PATIENT WAS TREATED WITH ANTIBIOTICS. ON (B)(6) 2019 PATIENT 2 RESULTS WERE NEGATIVE FOR ALL PARAMETERS. THE PATIENT'S CULTURE CAME BACK AS GREATER THAN 100,000 CFU/ML KLEBSIELLA ON (B)(6) 2019. WHEN THE CULTURE WAS RECEIVED, THE PATIENT WAS TREATED WITH ANTIBIOTICS. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED DUE TO DELAYING TREATMENT BY WAITING ON THE CULTURE RESULTS. THE INSTRUMENT HAS BEEN CALIBRATED. THE CUSTOMER DOES NOT PERFORM QC ON THE INSTRUMENT. THE INSTRUMENT AND TEST STRIPS WERE REQUESTED FOR INVESTIGATION, HOWEVER, THE CUSTOMER HAS DISCARDED THE TEST STRIPS.

Additional Manufacturer Narrative

TESTING OF RETENTION MATERIAL LOT 27638300 WAS COMPLETED USING A RETENTION URISYS 1800 ANALYZER, WITH RESULT FULFILLING ROCHE REQUIREMENTS. A FALSE NEGATIVE WAS NOT OBSERVED. NO CUSTOMER PRODUCT WAS PROVIDED. ALTHOUGH THE ISSUE COULD NOT BE CONFIRMED, A LIMIT OR DETECTION ISSUE CANNOT BE EXCLUDED.

Additional Manufacturer Narrative

THE CUSTOMER RETURNED THE AFFECTED URISYS 1100 URINE ANALYZER SERIAL NUMBER (B)(4) AND CHEMSTRIPS LOT NUMBER 27638305. THERE WERE NOT DAMAGES VISUALLY. AS THE RETURNED CHEMSTRIP HAS EXPIRED, RETENTION LOT NUMBER 36254580 WAS USED. THE RETENTION CHECMSTRIPS WERE MEASURED ON THE RETURNED ANALYZER. THE MEASUREMENTS WITH THE RETURNED METER DO NOT MEET ROCHE SPECIFICATION. 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.