URISYS 2400 CASSETTE [400 TESTS]

Additional Manufacturer Narrative

THE CUSTOMER CHANGED THE CASSETTE, RAN CALIBRATION WHICH PASSED AND CLEANED THE INSTRUMENT. QC WAS RERUN BUT THE ISSUE WAS NOT RESOLVED. THE CUSTOMER STOPPED USING THE INSTRUMENT AND IS RUNNING PATIENT SAMPLES ON THE CLINITEK INSTRUMENT. THE CASSETTE WAS REQUESTED FOR INVESTIGATION; HOWEVER, THE CUSTOMER HAS DISCARDED THE ACTUAL CASSETTE IN USE. THE CUSTOMER INTENDS TO SEND A DIFFERENT CASSETTE WITH THE SAME LOT NUMBER FOR INVESTIGATION. THE FIELD SERVICE ENGINEER (FSE) FOUND A SAMPLE TUBE LEAKING IN A CELL. THE FSE REPLACED THE TUBE GOING TO THE SAMPLE PROBE AND REBUILT SYRINGES AND CLEANED THE SYSTEM. CALIBRATION, QC, MECHANISM CHECKS AND DIAGNOSTIC CHECKS WERE ALL ACCEPTABLE. THE INSTRUMENT HAS BEEN WORKING WELL SINCE THE SERVICE VISIT.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF QC ISSUES AND FALSE NEGATIVE RESULTS FOR 1 PATIENT TESTED FOR LEUKOCYTES WITH THE URISYS 2400 CASSETTE ON A URISYS 2400 AUTOMATED URINE ANALYZER WITH SERIAL NUMBER (B)(4). THE INITIAL LEUKOCYTES RESULT FROM THE URISYS 2400 ANALYZER WAS NEGATIVE AT 1:42 A.M. THE NEGATIVE RESULTS FROM THE URISYS 2400 WERE REPORTED OUTSIDE OF THE LABORATORY AND WERE QUESTIONED BY THE PHYSICIAN AS A UTI WAS SUSPECTED. THE PHYSICIAN REQUESTED A RECOLLECTION OF THE PATIENT SAMPLE. THE NEW SAMPLE WAS RUN ON THE URISYS 2400 ANALYZER AT 5:30 A.M. AND THE LEUKOCYTES RESULT WAS NEGATIVE. THE NEW SAMPLE WAS RUN ON THE CLINITEK INSTRUMENT AT 5:39 A.M. AND THE LEUKOCYTES RESULT WAS SMALL (1+). AT 5:25 A.M. MICROSCOPIC TESTS WERE PERFORMED WITH THE FOLLOWING RESULTS: WBC= 10-25/HPF, RBC=10-25/HPF, BACTERIA 3+. THESE RESULTS SUGGEST THE POSITIVE RESULTS FROM THE CLINITEK INSTRUMENT WERE CORRECT. THE FIRST SAMPLE WAS RUN ON THE CLINITEK INSTRUMENT AT 5:53 A.M. AND THE LEUKOCYTES RESULT WAS LARGE (3+). THE POSITIVE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE PATIENT WAS DIAGNOSED AND TREATED FOR ACUTE CYSTITIS (UTI).

Additional Manufacturer Narrative

THE CUSTOMER MATERIAL OF LOT 37882400 WAS INSTALLED ON AN IU U2400 ANALYZER AND WAS TESTED WITH BIORAD QUANTIFY PLUS CONTROL LEVEL 2 LOT 79702 AND WAS ALSO TESTED WITH 0-NATIVE-URINE, A NITRITE-DILUTION-SERIES, A KETONE-DILUTION-SERIES, A LEUCOZYTES-DILUTION-SERIES AND AN ERYTHROCYTES-DILUTION-SERIES. THE RETURNED CASSETTE FUNCTIONED AS SPECIFIED. THE CUSTOMER MATERIAL SHOWS NO FALSE NEGATIVE RESULTS. THE MATERIAL SHOWS ALSO NO ABNORMALITIES AND FULFILLS OUR REQUIREMENTS.. ALL VALUES MET THE RESPECTIVE TARGET RANGE. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED.