BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE 9180 ELECTROLYTE ANALYZER

    MDR report key: 23509020 · Received November 10, 2025

    Report

    Report Number
    1823260-2025-04555
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 18, 2025
    Report Date
    December 18, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFP
    UDI-DI
    04015630031832
    PMA / PMN Number
    K961458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER WAS USING EITHER SODIUM ELECTRODE LOT 31244547 OR 31244548. THESE HAVE AN INSTALL BEFORE DATE OF (B)(6) 2025. ALL ELECTRODES WERE INSTALLED BY THE CUSTOMER IN (B)(6) 2025, THEREFORE THE ELECTRODE WAS EXPIRED AT THE TIME OF INSTALLATION. THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH USE OF AN EXPIRED ELECTRODE. THE CUSTOMER WAS USING A REFERENCE ELECTRODE MANUFACTURED BY DIAMOND DIAGNOSTICS (DD REF ELECTRODE) 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 ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER CONSIDERED THE REPEAT RESULT TO BE CORRECT AS IT CORRELATED TO THE PATIENT'S CLINICAL FINDINGS.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE SODIUM ELECTRODE ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 110 MMOL/L. THE SYSTEM WAS RE-CALIBRATED AND THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 139 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1927148 ROCHE 9180 ELECTROLYTE ANALYZER ELECTROLYTE ANALYZER JFP ROCHE DIAGNOSTICS 04015630031832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown