BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE 9180 ELECTROLYTE ANALYZER

    MDR report key: 23111536 · Received September 22, 2025

    Report

    Report Number
    1823260-2025-03371
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    August 28, 2025
    Report Date
    November 11, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFP
    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 SODIUM ELECTRODE AND CALCIUM LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. 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 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

    IMAGES WITH THE LOT NUMBERS FOR CALCIUM AND SODIUM WERE PROVIDED. THE CALCIUM LOT NUMBER IS 110734, AND THE EXPIRATION DATE WAS NOT PROVIDED. THE SODIUM LOT NUMBER IS 407289, AND THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM AND CALCIUM RESULTS FROM THE ROCHE 9180 ELECTROLYTE ANALYZER. RESULTS WERE PROVIDED FOR SIX PATIENTS. PATIENT ONE'S INITIAL SODIUM RESULT WAS 115 MMOL/L. A REPEAT RESULT ON A COBAS 6000 WAS 135 MMOL/L. PATIENT TWO'S INITIAL SODIUM RESULT ON (B)(6) 2025 WAS 116 MMOL/L, WITH A REPEAT RESULT OF 139 MMOL/L. THE PATIENT'S INITIAL CALCIUM RESULT WAS 1.13 MMOL/L, WITH A REPEAT RESULT OF 0.456 MMOL/L. PATIENT THREE'S INITIAL SODIUM RESULT ON (B)(6) 2025 WAS 115 MMOL/L, WITH A REPEAT RESULT OF 136 MMOL/L. PATIENT FOUR'S INITIAL SODIUM RESULT ON (B)(6) 2025 WAS 116 MMOL/L, WITH A REPEAT RESULT OF 136 MMOL/L. PATIENT FIVE'S INITIAL SODIUM RESULT ON (B)(6) 2025 WAS 115 MMOL/L, WITH A REPEAT RESULT OF 132 MMOL/L. PATIENT SIX'S INITIAL SODIUM RESULT ON (B)(6) 2025 WAS 113 MMOL/L, WITH A REPEAT RESULT OF 135 MMOL/L. THE QUESTIONABLE RESULT FOR PATIENT ONE WAS NOT RELEASED OUTSIDE OF THE LABORATORY, AS IT WAS REPEATED BECAUSE OF THE LOW RESULT. IT WAS NOT PROVIDED WHETHER THE OTHER PATIENT'S RESULTS WERE RELEASED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2655477 ROCHE 9180 ELECTROLYTE ANALYZER ELECTROLYTE ANALYZER JFP ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown