BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE 9180 ELECTROLYTE ANALYZER

    MDR report key: 23464178 · Received November 4, 2025

    Report

    Report Number
    1823260-2025-04479
    Event Type
    Malfunction
    Date Received
    November 4, 2025
    Date of Event
    October 15, 2025
    Report Date
    November 26, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFP
    UDI-DI
    04015630031832
    PMA / PMN Number
    K961458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THE ISSUE WAS RELATED TO A REFERENCE ELECTRODE MANUFACTURED BY DIAMOND DIAGNOSTICS (DD REF ELECTRODE) USED WITH THE 9180 ELECTROLYTE ANALYZER. THE REFERENCE ELECTRODE USED (DD REF ELECTRODE) IS COVERED BY A ROCHE INITIATED RECALL. CUSTOMERS USING THE DD REF ELECTRODE WERE INSTRUCTED TO IMMEDIATELY STOP USING SODIUM (NA) RESULTS FROM THEIR 9180 ANALYZER. THE AFFECTED REFERENCE ELECTRODE WAS NOT DISTRIBUTED IN THE UNITED STATES. CUSTOMERS IN THE UNITED STATES USE ROCHE REFERENCE ELECTRODE AND REFERENCE ELECTRODE HOUSING. NO FURTHER ACTION IS NEEDED FOR CUSTOMERS IN THE UNITED STATES.

    Additional Manufacturer Narrative · 0

    THE SODIUM ELECTRODE LOT NUMBER WAS 31250547, AND THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE SODIUM ELECTRODE RESULT FROM THE ROCHE 9180 ELECTROLYTE ANALYZER FOR TWO PATIENTS. PATIENT 1'S INITIAL RESULT WAS 134 MMOL/L, AND THE REPEAT RESULT WAS 143 MMOL/L. PATIENT 2'S INITIAL RESULT WAS 132 MMOL/L, AND THE REPEAT RESULT WAS 149 MMOL/L. THE CUSTOMER IS UNSURE WHICH RESULTS ARE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215872 ROCHE 9180 ELECTROLYTE ANALYZER ELECTROLYTE ANALYZER JFP ROCHE DIAGNOSTICS 04015630031832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown