COBAS U PACK (400 STRIPS)

Additional Manufacturer Narrative

THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH THE CUSTOMER MODIFYING THE RANGE TABLE SETTINGS OF THE U 601 ANALYZER. THE U 601 ANALYZER PROVIDES A SEMI QUANTITATIVE RESULT AS A RANGE. DIFFERENT SYSTEMS MAY PROVIDE SLIGHTLY DIFFERENT RESULTS EVEN WHEN REPEATING A MEASUREMENT FROM THE SAME SAMPLE. THIS IS DUE TO SLIGHT DIFFERENCE OF PARTS LIKE THE LED , DETECTION SENSOR , AND TEST STRIP RECIPE. DESPITE THE REPORTED DISCREPANCY, THE AMOUNT OF DISCREPANT RESULTS COMPARED TO ALL MEASUREMENTS IS STILL ACCEPTABLE ACCORDING TO THE PERFORMANCE DATA AND MEET SPECIFICATIONS. THE RANGE LIMIT FOR WAS MODIFIED LOCALLY TO MAKE U 601 LESS SENSITIVE.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE U 601 ANALYZER IS (B)(6). THE INVESTIGATION IS ONGOING. MEDWATCH FIELD E1 INITIAL REPORTER ESTABLISHMENT NAME - THE FULL NAME WAS PROVIDED AS "(B)(6) HOSPITAL AFFILIATED TO (B)(6) HOSPITAL OF (B)(6) UNIVERSITY". THE E1 INITIAL REPORTER EMAIL ADDRESS WAS PROVIDED AS "(B)(6)".

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE NEGATIVE LEUKOCYTE RESULTS FOR TWO PATIENT SAMPLES TESTED WITH A COBAS U PACK ON A COBAS U 601 URINE ANALYZER. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE ANALYZER RESULTS DID NOT MATCH THE CLINICAL DIAGNOSES OF THE PATIENTS. THE PATIENTS DID NOT HAVE ANY DISEASE. THE FIRST SAMPLE RESULTED IN A NEGATIVE LEUKOCYTE VALUE ON THE U 601 ANALYZER AND WHEN CHECKED ON A URINE MICROSCOPY ANALYZER, THE RESULT WAS 112.20 LEUKOCYTES/UL. THE SAMPLE WAS ALSO TESTED ON A SECOND URINE ANALYZER (COBAS U 411) AND THE LEUKOCYTE RESULT WAS 1+. A MANUAL MICROSCOPY READ OF THE URINE SAMPLE SHOWED MANY LEUKOCYTES (A SPECIFIC VALUE COULD NOT BE PROVIDED). THE SECOND SAMPLE RESULTED IN A NEGATIVE LEUKOCYTE VALUE WHEN TESTED ON THE U 601 ANALYZER ON (B)(6) 2025. WHEN CHECKED ON THE URINE MICROSCOPY ANALYZER ON (B)(6) 2025, THE RESULT WAS 87.12 LEUKOCYTES/UL. THE SAMPLE WAS TESTED ON THE SECOND URINE ANALYZER ON (B)(6) 2025, RESULTING IN A 1+ LEUKOCYTE RESULT. A MANUAL MICROSCOPY READ OF THE URINE SAMPLE SHOWED MANY LEUKOCYTES (A SPECIFIC VALUE COULD NOT BE PROVIDED).

Additional Manufacturer Narrative

THE CUSTOMER ALLEGED THAT ONE OF THE TWO PATIENTS RECEIVED TREATMENT FOR A URINARY TRACT INFECTION. IT WAS NOT SPECIFIED WHICH PATIENT RECEIVED TREATMENT OR WHAT THE SPECIFIC TREATMENT WAS. THIS PATIENT WAS FEMALE.