BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PROTEIN URINE/CSF GEN.3

    MDR report key: 24039075 · Received January 12, 2026

    Report

    Report Number
    1823260-2026-00147
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    December 12, 2025
    Report Date
    May 12, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIQ
    UDI-DI
    04015630919536
    PMA / PMN Number
    K141925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT'S DIAGNOSIS IS LEFT MULTICYSTIC DYSPLASTIC KIDNEY.

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99671 TOTAL PROTEIN URINE/CSF GEN.3 TURBIDIMETRIC, TOTAL PROTEIN JIQ ROCHE DIAGNOSTICS 89434401 04015630919536

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Unknown