URISYS 2400

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER (FSE) FOUND THE GRIPPER FINGERS WERE CORRODED AND STICKING CAUSING THE TEST STRIPS TO NOT FEED CORRECTLY. THE GRIPPER FINGERS AND TEST STRIP GUIDES WERE REPLACED. THE TEST STRIPS FEED SUCCESSFULLY AND THE CUSTOMER RAN CALIBRATION AND QC SUCCESSFULLY. FOLLOWING THE SERVICE VISIT, THE CUSTOMER COMPLAINED OF AN ADDITIONAL PATIENT SAMPLE WITH A FALSE POSITIVE NITRITE RESULT. THE RESULT WAS COMPARED WITH A DIPSTICK STRIP TEST AND THE RESULT WAS NEGATIVE. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF FALSE POSITIVE RESULTS FOR 2 PATIENT SAMPLES TESTED FOR NITRITES ON A URISYS 2400 URINE ANALYZER. THE POSITIVE RESULTS FOR BOTH PATIENTS WERE REPORTED OUTSIDE OF THE LABORATORY BUT WERE NOT FINALIZED UNTIL CONFIRMATION TESTING WAS PERFORMED. BOTH SAMPLES WERE MANUALLY RE-RUN BY DIPSTICK TESTING AND WERE ALSO REVIEWED MICROSCOPICALLY AND FOUND TO BE NEGATIVE. CORRECTED REPORTS WERE ISSUED TO REFLECT THE NEGATIVE RESULTS. THE URISYS 2400 CASSETTE REAGENT LOT NUMBER WAS 40790200 WITH AN EXPIRATION DATE OF 31-MAY-2020.

Additional Manufacturer Narrative

NO CUSTOMER MATERIAL WAS RECEIVED FOR INVESTIGATION. THE RETENTION MATERIAL OF LOT 40790200 WAS MEASURED ON AN URISYS 2400 ANALYZER WITH 0-NATIVE-URINE AND A NITRITE-DILUTION-SERIES ACCORDING TO THE TESTING PLAN. NO FALSE POSITIVE RESULTS WERE RECEIVED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.