TOTAL PROTEIN URINE/CSF GEN.3

Additional Manufacturer Narrative

THE COBAS INTEGRA 400 PLUS SERIAL NUMBER WAS (B)(6). BASED ON THE PROVIDED DATA, A GENERAL REAGENT PROBLEM COULD BE EXCLUDED BECAUSE CALIBRATION AND QUALITY CONTROL WERE ACCEPTABLE. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE TOTAL PROTEIN URINE/CSF GEN.3 RESULTS FROM THE COBAS INTEGRA 400 PLUS ANALYZER. PATIENT 1 INITIAL RESULT WAS 275.03 MG/L, AND THE REPEAT RESULT IN ANOTHER LABORATORY WAS 82.1 MG/L. PATIENT 2 INITIAL RESULT WAS 105.5 MG/L, AND THE REPEAT RESULT IN ANOTHER LABORATORY WAS 68.1 MG/L.

Additional Manufacturer Narrative

DUE TO THE LIMITED INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THERE WAS NO PRODUCT PROBLEM IDENTIFIED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS PROVIDED FOR THE DATES OF THE QUESTIONABLE RESULTS. PATIENT 1 OCCURRED ON (B)(6) 2025. PATIENT 2 OCCURRED ON (B)(6) 2025. MEDWATCH FIELD B3 DATE OF EVENT WAS UPDATED.