BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 303 ANALYTICAL UNIT

    MDR report key: 24051304 · Received January 13, 2026

    Report

    Report Number
    1823260-2026-00157
    Event Type
    Malfunction
    Date Received
    January 13, 2026
    Date of Event
    December 23, 2025
    Report Date
    February 12, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K220134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ELECTRODE LOT NUMBER WAS EQE95. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER REPLACED THE SAMPLE PROBE, SIPPER, SIPPER TUBE, PINCH TUBE, VACUUM NOZZLE, ISE DEGASSER, AND PRESSURE SENSOR. HE DECONTAMINATED, THEN REPLACED THE ISE DILUTION CUP AND PERFORMED ISE FLOW PATH CLEANINGS. THE FIELD SERVICE ENGINEER PERFORMED A WATER ADJUSTMENT, REPLACED THE GEAR PUMP HEAD, ADJUSTED THE VALUE AND VOLTAGE, CHECKED THE RINSE STATION WATER VOLUME, CELL RINSE WATER VOLUME, AND THE DETERGENT CONSUMPTION. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER REPLACED AND ADJUSTED THE COMPLETE ISE UNIT, A SOLENOID VALVE, SAMPLE PROBE UNIT, AND GEAR PUMP. HE CLEANED THE FLUIDIC BATH, CONFIRMED THE RINSE FLOW FOR THE SAMPLE PROBE, AND CONFIRMED THE WATER QUALITY. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM RESULTS FROM THE COBAS PURE C 303 ANALYTICAL UNIT. EXAMPLE 1 INITIAL RESULT WAS 146.5 MMOL/L, AND THE REPEAT RESULTS WERE 136.5 MMOL/L AND 136.5 MMOL/L. ON (B)(6) 2025, EXAMPLE 2 INITIAL RESULT WAS 165.3 MMOL/L WITH A DATA FLAG. THE REPEAT RESULT FROM ANOTHER ANALYZER WAS 144 M MOL/L. ON (B)(6) 2025, EXAMPLE 3 INITIAL RESULT WAS 160.4 MMOL/L WITH A DATA FLAG. ON (B)(6) 2025, THE REPEAT RESULTS WERE 170.3 MMOL/L WITH A DATA FLAG AND 162.6 MMOL/L WITH A DATA FLAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113022 COBAS C 303 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown