BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PROTEIN URINE/CSF GEN.3

    MDR report key: 22229255 · Received June 17, 2025

    Report

    Report Number
    1823260-2025-01860
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    May 12, 2025
    Report Date
    June 3, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIQ
    UDI-DI
    04015630919536
    PMA / PMN Number
    K141925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    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 · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102637 TOTAL PROTEIN URINE/CSF GEN.3 TURBIDIMETRIC, TOTAL PROTEIN JIQ ROCHE DIAGNOSTICS 852901 04015630919536

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female QUENSYL| SULFASALAZINE