BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 23211491 · Received October 3, 2025

    Report

    Report Number
    1823260-2025-04059
    Event Type
    Malfunction
    Date Received
    October 3, 2025
    Date of Event
    September 14, 2025
    Report Date
    October 21, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D, DEVICE IDENTIFICATION, WAS UPDATED. RELEVANT FIELDS OF SECTIONS D AND G WERE UPDATED. THE CA2 REAGENT LOT NUMBER WAS 880047 WITH AN EXPIRATION DATE OF 31-AUG-2026. THE FIELD SERVICE ENGINEER (FSE) REPLACED A SAMPLE PROBE AND PERFORMED ADJUSTMENTS. QC WAS ACCEPTABLE. THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO A MAINTENANCE ISSUE.

    Additional Manufacturer Narrative · 0

    THE C503 ANALYZER SERIAL NUMBER WAS (B)(6). THE FIELD SERVICE ENGINEER (FSE) OBSERVED CRYSTALLIZATION ON TOP OF THE CUVETTES AND CELL RINSE OVERFLOWING DURING MECHANISM CHECKS. THE FSE FLUSHED THE SOLENOID VALVES, THE CUVETTE RINSE NOZZLES, AND THE CHECK VALVE. THE VACUUM PUMP FILTER WAS REPLACED, THE GEAR PUMP WAS ADJUSTED, THE REAGENT AND SAMPLE PROBE RINSE VOLUMES WERE ADJUSTED, AND THE CUVETTE RINSE, BLANK CELL, AND ACID WASH VOLUMES WERE ADJUSTED. MECHANISM CHECKS WERE COMPLETED WITH NO ISSUES, AND THE RINSE LEVELS WERE WITHIN SPECIFICATION. PRECISION RESULTS WERE ACCEPTABLE. THE CUSTOMER HAS HAD NO FURTHER ISSUES SINCE THE SERVICE VISIT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR CALCIUM GEN.2 (CA2) ON A COBAS C 503 ANALYTICAL UNIT. AN EXAMPLE OF DISCREPANT RESULTS WAS PROVIDED FOR 1 PATIENT SAMPLE. THE INITIAL RESULT WAS 5.3 MG/DL. THE REPEAT RESULT WAS 8.6 MG/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1589369 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 08057427190 880047

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female