BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE 9180 ELECTROLYTE ANALYZER

    MDR report key: 23585450 · Received November 18, 2025

    Report

    Report Number
    1823260-2025-04687
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 26, 2025
    Report Date
    December 5, 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 ELECTRODE LOT NUMBER IS 31244547. THE EXPIRATION DATE WAS REQUESTED, BUT IT WAS NOT PROVIDED. CALIBRATION AND QC WERE WITHIN THE EXPECTED RANGES. THE INVESTIGATION IS ONGOING.

    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 (B)(4) 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 (B)(4) 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.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE RESULTS WITH MULTIPLE PATIENT SAMPLES ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE FOLLOWING EXAMPLE FOR ONE PATIENT WAS PROVIDED: THE INITIAL RESULT WAS 113 MMOL/L. THE REPEAT RESULTS WERE 113 MMOL/L AND 139 MMOL/L, RESPECTIVELY. THE NORMAL RESULT WAS DEEMED CORRECT (139 MMOL/L).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2316356 ROCHE 9180 ELECTROLYTE ANALYZER ELECTROLYTE ANALYZER JFP ROCHE DIAGNOSTICS 04015630031832

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male