BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE 9180 ELECTROLYTE ANALYZER

    MDR report key: 22628877 · Received July 28, 2025

    Report

    Report Number
    1823260-2025-02300
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    July 7, 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
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SODIUM ELECTRODE LOT NUMBER WAS 31250347, WITH AN INSTALL-BEFORE DATE OF 12-SEP-2025. THE CUSTOMER CHANGED A SYSTEM REAGENT PACK AND NOTICED AN IMPROVEMENT IN CONTROL PERFORMANCE AND SAMPLE REPRODUCIBILITY. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER LATER CLARIFIED THAT THE 142 MMOL/L SODIUM VALUE WAS CONSIDERED TO BE THE CORRECT VALUE.

    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 CALIBRATION VALUES FOR CALIBRATION STANDARD A FOR NA AND K WERE WITHIN RANGE, AND THE VOLTAGE DIFFERENCE IN THE CALIBRATION STANDARDS FOR NA AND CL WERE WITHIN THE ALLOWED RANGE. HOWEVER, THE K A-B VALUE WAS OUT OF RANGE IN THE 11:32 CALIBRATION, AND THE CL STAND A VALUE WAS OUT OF RANGE IN THE 17:35 CALIBRATION. NO CORRECTION FACTORS WERE APPLIED. THE INVESTIGATION FINDINGS SUGGEST THAT THE PROBLEM LIKELY STEMS FROM THE INTERPLAY BETWEEN SPECIFIC CORE COMPONENTS WITHIN THE SYSTEM (REFERENCE ELECTRODE, NA ELECTRODE, SYSTEM REAGENT PACK), ALONG WITH POTENTIAL DEFICIENCIES IN THE MAIN INSTRUMENT'S OPERATION. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT SODIUM ELECTRODE RESULTS FOR ONE PATIENT SAMPLE TESTED ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 142 MMOL/L AND IT REPEATED AS 170 MMOL/L. THE CUSTOMER DID NOT BELIEVE ANY OF THE VALUES TO BE CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AS THE RESULTS DID NOT MATCH THE PATIENT'S CLINICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1575205 ROCHE 9180 ELECTROLYTE ANALYZER ELECTROLYTE ANALYZER JFP ROCHE DIAGNOSTICS 04015630031832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown