BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE 9180 ELECTROLYTE ANALYZER

    MDR report key: 23235628 · Received October 7, 2025

    Report

    Report Number
    1823260-2025-04093
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    September 16, 2025
    Report Date
    November 21, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFP
    PMA / PMN Number
    K961458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE NA ELECTRODE LOT NUMBER WAS 407385. THE EXPIRATION DATE WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER USES REFERENCE ELECTRODES MANUFACTURED BY DIAMOND DIAGNOSTICS. 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 THE SODIUM (NA) RESULTS FROM THEIR 9180 ANALYZER. THE AFFECTED REFERENCE ELECTRODE WAS NOT DISTRIBUTED IN THE UNITED STATES. CUSTOMERS IN THE UNITED STATES USE THE ROCHE REFERENCE ELECTRODE AND THE REFERENCE ELECTRODE HOUSING. NO FURTHER ACTION IS NEEDED FOR CUSTOMERS IN THE UNITED STATES.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR SODIUM (NA) ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE RESULT FROM THE 9180 ELECTROLYTE ANALYZER WAS 119 MMOL/L. THE RESULT FROM A COBAS B221 BLOOD GAS ANALYZER WAS 135 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2746811 ROCHE 9180 ELECTROLYTE ANALYZER ELECTROLYTE ANALYZER JFP ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown