BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 23920788 · Received December 30, 2025

    Report

    Report Number
    1823260-2025-05363
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    December 10, 2025
    Report Date
    January 23, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924707
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER FOUND AN ISSUE WITH THE SAMPLE PROBE. HE REPLACED THE SAMPLE PROBE AND PERFORMED ADJUSTMENTS. HE RAN QC AND PRECISION, WHICH WERE WITHIN SPECIFICATION. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE K ELECTRODE LOT NUMBER WAS DYE WITH AN EXPIRATION DATE OF 04-MAY-2026. THE CL ELECTRODE LOT NUMBER WAS EAX WITH AN EXPIRATION DATE OF 15-MAR-2026.

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED ISE RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED ON A COBAS 6000 C (501) MODULE. THE CUSTOMER ALLEGED HAVING ISSUES SINCE (B)(6) 2025. THE FIELD SERVICE ENGINEER (FSE) ADJUSTED THE SAMPLE PROBE ON (B)(6) 2025. THE CUSTOMER WAS RECEIVING "ABNORMAL PROBE SUCKING" ERRORS SEVERAL HOURS BEFORE THE EVENT ON (B)(6) 2025. DISCREPANT RESULTS WERE PROVIDED FOR 1 PATIENT SAMPLE TESTED FOR ISE INDIRECT NA-K-CL FOR GEN.2 (CL) AND POTASSIUM ELECTRODE (K). THE INITIAL K RESULT WAS 5.7 MMOL/L. THE REPEAT RESULT WAS 4.2 MMOL/L. THE INITIAL CL RESULT WAS 68.7 MMOL/L. THE REPEAT RESULT WAS 98 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2327865 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male