TOTAL PROTEIN URINE/CSF GEN.3

Additional Manufacturer Narrative

THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. SINCE THERE IS NO IFCC REFERENCE METHOD OR REFERENCE MATERIAL FOR TOTAL PROTEIN URINE/CSF (TPUC), EACH MANUFACTURER CREATES ITS OWN REFERENCE STANDARDIZATION. TPUC IS A SCREENING METHOD. BECAUSE EVERY PATIENT POSSESSES A UNIQUE PROTEIN DISTRIBUTION, A SINGLE CALIBRATOR CANNOT FULLY REFLECT EVERY INDIVIDUAL CLINICAL PROFILE. CONSEQUENTLY, DIFFERENCES MAY OCCUR DEPENDING ON THE COMPOSITION OF THE CALIBRATOR AND THE DISTRIBUTION OF THE PATIENT¿S SPECIFIC PROTEIN FRACTIONS.

Additional Manufacturer Narrative

THE PATIENT'S DIAGNOSIS IS LEFT MULTICYSTIC DYSPLASTIC KIDNEY.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE C501 ANALYZER IS (B)(6). THE SERIAL NUMBER OF THE C303 ANALYZER WAS REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT URINE SAMPLE TESTED WITH TOTAL PROTEIN URINE/CSF GEN.3 ON A COBAS 6000 C501 MODULE AND A COBAS PURE C 303 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A TOTAL PROTEIN VALUE OF 135 MG/DL WHEN TESTED ON THE C501 ANALYZER. THE SAMPLE WAS USED AS PART OF A VALIDATION STUDY ON THE C303 ANALYZER AND MEASURED ON THAT SYSTEM ON (B)(6) 2025, RESULTING IN A TOTAL PROTEIN VALUE OF 195 MG/DL. THE SAMPLE WAS THEN TESTED WITH A COMPETITOR METHOD (KANTO CHEMICAL), RESULTING IN A TOTAL PROTEIN VALUE OF < 1.27 MG/DL WITH A DATA FLAG. THE COMPETITOR METHOD IS A PYRAGALLOL RED METHOD. A URINE TEST STRIP HAD A NEGATIVE TOTAL PROTEIN VALUE. AN ADDITIONAL BLOOD TEST FOR TOTAL PROTEIN WAS PERFORMED FOR THE PATIENT AND BASED ON THAT CLINICAL OUTCOME, THE C501 RESULT IS BELIEVED TO BE INCORRECT. NO SPECIFIC RESULTS WERE PROVIDED.