TOTAL PROTEIN URINE/CSF GEN.3

Additional Manufacturer Narrative

THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT WAS CONSISTENT WITH AN ABNORMAL AND CONSPICUOUS REACTION CAUSED BY THE USAGE OF NON-ROCHE, NOT SUPPORTED PARTNER CHANNELS REAGENTS, LEADING TO AN UNKNOWN CARRY-OVER INTERFERENCE.

Additional Manufacturer Narrative

THE COBAS 8000 C702 MODULE SERIAL NUMBER WAS (B)(6). THE SAMPLE AND REAGENT NEEDLES WERE NOT CLEANED REGULARLY, AND THEY WERE ONLY CLEANED WHEN THEY WERE FOUND TO BE DIRTY. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION OF A DISCREPANT RESULT FOR 1 PATIENT'S URINE SAMPLE TESTED WITH TOTAL PROTEIN URINE/CSF GEN.3 (TPUC3) ASSAY ON A COBAS 8000 C702 MODULE. ON (B)(6) 2025, THE INITIAL RESULT WAS 75 MG/L. ON (B)(6) 2025, A NEW URINE SPECIMEN WAS TAKEN FROM THE PATIENT AND TESTED ON A MINDRAY INSTRUMENT USING THE PYROGALLOL RED MOLYBDENUM METHOD IN A DIFFERENT HOSPITAL, RESULTING IN A URINE TOTAL PROTEIN VALUE OF 24 MG/L; THE ROUTINE URINE TEST WAS NEGATIVE. THE REPORTER DEEMED THE INITIAL RESULT FROM THE MODULE WAS TOO HIGH. ON (B)(6) 2025, THE REPEAT RESULT OF THE INITIAL PATIENT SAMPLE AFTER DILUTION WAS 128 MG/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY, AS IT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. THE INITIAL RESULT WAS DEEMED TO BE CORRECT.