BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 23839481 · Received December 18, 2025

    Report

    Report Number
    1823260-2025-05211
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    December 4, 2025
    Report Date
    March 18, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924707
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SODIUM ELECTRODE LOT NUMBER WAS EDY, THE POTASSIUM ELECTRODE LOT NUMBER WAS DYQ, AND THE CHLORIDE ELECTRODE LOT NUMBER WAS EBB. THE ELECTRODE EXPIRATION DATES WERE REQUESTED, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER FOUND THERE WAS NO VACUUM ON A RINSE NOZZLE. THE CELL RINSE WATER LEVELS WERE INCONSISTENT. THE RINSE SYSTEM WAS CLEANED. THE RINSE TUBING WAS ADJUSTED AND VACUUM WAS WORKING PROPERLY AFTERWARDS. THE SIPPER FLOW PATH WAS CLEANED. THE SIPPER AND ISE PROBE ADJUSTMENTS WERE CHECKED. CALIBRATIONS PASSED AFTER CONDITIONING. PRECISION STUDIES PASSED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE SODIUM ELECTRODE EXPIRATION DATE WAS (B)(6) 2026. THE POTASSIUM ELECTRODE EXPIRATION DATE WAS (B)(6) 2026. THE CHLORIDE ELECTRODE EXPIRATION DATE WAS (B)(6) 2026. CALIBRATION DATA WAS ONLY PROVIDED FOR SODIUM. MULTIPLE CALIBRATIONS WERE PERFORMED ON THE DAY OF THE EVENT. CALIBRATION WERE SUCCESSFUL, BUT SHOWED A LARGE AMOUNT OF VARIATION. THE FIELD SERVICE ENGINEER RETURNED AND RE-INSTALLED THE RINSE TUBING VACUUM LINE AND REPLACED A VALVE BLOCK DUE TO A CRACK. ANOTHER VALVE BANK WAS REPLACED AND A RINSE WATER CHECK VALVE WAS REPLACED. THE RINSE LEVELS WERE ADJUSTED. CALIBRATION AND CONTROLS WERE RUN. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT SODIUM ELECTRODE, POTASSIUM ELECTRODE, AND CHLORIDE ELECTRODE RESULTS FOR ONE PATIENT SAMPLE TESTED ON A COBAS 6000 C (501) MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN THE FOLLOWING VALUES: SODIUM = 103 MMOL/L. POTASSIUM = 3.43 MMOL/L. CHLORIDE = 72.5 MMOL/L. THE CUSTOMER DID NOT BELIEVE THE RESULTS WERE ACCURATE, SO THE PATIENT SAMPLE WAS REPEATED ON A SECOND ANALYZER. THE REPEAT RESULTS FROM THE SAMPLE WERE AS FOLLOWS: SODIUM = 131 MMOL/L POTASSIUM = 4.41 MMOL/L CHLORIDE = 93 MMOL/L THE REPEAT VALUES WERE DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238117 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown