BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 23841491 · Received December 18, 2025

    Report

    Report Number
    1823260-2025-05223
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Date of Event
    November 25, 2025
    Report Date
    January 26, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924707
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO INDICATION OF A PERFORMANCE ISSUE WITH THE REAGENT SINCE THE QC WAS WITHIN THE RANGES. THE FIELD SERVICE ENGINEER FOUND THAT THE CAUSE WAS DUE TO A CONTAMINATED ION-SELECTIVE ELECTRODE (ISE) FLOW PATH. HE DECONTAMINATED THE ISE FLOW PATH. HE THEN PERFORMED ISE CHECKS, CALIBRATION, AND QC, AND THEY WERE ALL WITHIN SPECIFICATIONS. THE SERVICE ACTIONS PERFORMED BY THE ENGINEER RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT.

    Additional Manufacturer Narrative · 0

    THE SODIUM ELECTRODE LOT NUMBER WAS DNA 75 WITH AN EXPIRATION DATE OF 08-MAR-2026. THE ISE INDIRECT NA-K-CL FOR GEN.2 ELECTRODE LOT NUMBER WAS DYX 21 WITH AN EXPIRATION DATE OF 24-FEB-2026. THE QC WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE AND ISE INDIRECT NA-K-CL FOR GEN.2 ELECTRODE RESULTS FOR 1 PATIENT SAMPLE TESTED ON A COBAS 6000 C 501 (UL) V MODULE. SODIUM: INITIAL RESULT: 167 MMOL/L. REPEAT RESULT: 141 MMOL/L. CHLORIDE: INITIAL RESULT: 84 MMOL/L. REPEAT RESULT: 105 MMOL/L. THE HIGH SODIUM RESULTS PROMPTED THE REPEAT OF THE SAMPLE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251650 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630924707

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female