TOTAL PROTEIN URINE/CSF GEN.3

Description of Event or Problem

THERE WAS AN ALLEGATION OF A QUESTIONABLE TOTAL PROTEIN URINE/CSF GEN.3 RESULT FROM THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 493 MG/L WITH AN ALBUMIN-URINE RESULT OF <13 MG/L. AT ANOTHER CLINIC THE RESULT WAS 438 MG/L, WITH NORMAL ALBUMIN, IMMUNOGLOBULIN G, AND A1MG CONCENTRATIONS, AND NORMAL URINE IMMUNOFIXATION RESULTS. ANOTHER LABORATORY RESULT WAS 458 MG/L, WITH NORMAL ELECTROPHORESIS. ANOTHER MEASUREMENT OF THE SAME SAMPLE WAS COMPLETED USING THE PYROGALLOL RED METHOD ON A DIFFERENT INSTRUMENT AND GAVE A RESULT OF <40 MG/L. THE RESULT OF <40 MG/L IS BELIEVED TO BE CORRECT IN COMPARISON TO THE OTHER URINE RESULTS.

Additional Manufacturer Narrative

THE COBAS 8000 COBAS C 502 MODULE SERIAL NUMBER IS (B)(6) THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative

SAMPLE MATERIAL WAS RECEIVED FOR INVESTIGATION. THE SAMPLE WAS TESTED ON A COBAS C502 INSTRUMENT. THE CUSTOMER'S RESULTS WERE PARTIALLY CONFIRMED. FURTHER INVESTIGATION WAS PERFORMED AT ANOTHER LABORATORY USING A COBAS C502 MODULE, A COBAS C503 MODULE, AND AN INTEGRA 400 ANALYZER. THE RESULTS FROM THE INVESTIGATION CONFIRMED AN INTERFERENCE WITH SULFASALAZINE. THE INTERFERENCE IS LIKELY DUE TO THE DRUG¿S ORANGE DISCOLORATION AND/OR CLOUDING DURING THE REACTION PHASE. THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO AN INTERFERENCE WITH SULFASALAZINE, INDICATING A POTENTIAL FACTOR OR ISSUE WHEN THIS MEDICATION IS PRESENT.

Additional Manufacturer Narrative

MEDWATCH SECTION A PATIENT INFORMATION A2, A3, AND A4 UPDATED. MEDWATCH SECTION D. SUSPECT MEDICAL DEVICE, 10. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDES TREATMENT OF EVENT) SECTION UPDATED. THE PATIENT IS DIAGNOSED WITH LUPUS ERYTHEMATOSUS WITH CUTANEOUS MANIFESTATIONS AND JOINT INVOLVEMENT. THE PATIENT ALSO HAS ULCERATIVE COLITIS, ARTERIAL HYPERTENSION, HYPERCHOLESTEROLEMIA, CIRCUMSCRIBED EMPHYSEMATOUS DESTRUCTION WITH PULMONARY HYPERINFLATION, WITH A HISTORY OF PNEUMONIA. THE PATIENT USES NICOTINE. THE PATIENT HAS THORACIC SCOLIOSIS AND SEVERE LIVER TOXICITY. THE PATIENT ALSO EXPERIENCED WEIGHT LOSS. THE INVESTIGATION IS ONGOING.