BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE 9180 ELECTROLYTE ANALYZER

    MDR report key: 22372483 · Received July 1, 2025

    Report

    Report Number
    1823260-2025-02004
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    May 23, 2025
    Report Date
    November 6, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFP
    PMA / PMN Number
    K961458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROCHE 9180 ELECTROLYTE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELDS D. DEVICE IDENTIFICATION, G1 AND G4 PMA / 510K (PREMARKET NUMBERS) UPDATED. ON THE FIELD SERVICE ENGINEER'S INITIAL SERVICE VISIT, HE INSPECTED THE ANALYZER AND REPLACED THE REFERENCE, SODIUM, AND CHLORIDE ELECTRODES. HE ALSO PERFORMED PREVENTIVE MAINTENANCE, REPLACED THE TUBING, SYSTEM REAGENTS, MAIN BOARD, AND PRINTER. ON HIS FOLLOW-UP SERVICE VISIT, HE AGAIN REPLACED THE REFERENCE ELECTRODE. THE INVESTIGATION DETERMINED THAT THE EVENT WAS CONSISTENT WITH THE INTERPLAY BETWEEN SPECIFIC CORE COMPONENTS WITHIN THE SYSTEM (NON-ROCHE REFERENCE ELECTRODE, SODIUM ELECTRODE, AND SYSTEM REAGENTS). THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    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 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 RECEIVED QUESTIONABLE ROCHE 9180 SODIUM ELECTRODE, ROCHE 9180 POTASSIUM ELECTRODE, AND ROCHE 9180 CHLORIDE ELECTRODE ASSAY RESULTS FROM SEVERAL PATIENT SAMPLES TESTED ON THE ROCHE 9180 ELECTROLYTE ANALYZER. THIS MEDWATCH IS FOR THE ROCHE 9180 POTASSIUM ELECTRODE ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER: (B)(6) - FOR THE ROCHE 9180 CHLORIDE ELECTRODE ASSAY. (B)(6) - FOR THE ROCHE 9180 SODIUM ELECTRODE ASSAY. THE REPORTER PROVIDED THE FOLLOWING EXAMPLES OF DISCREPANT RESULTS: THE HIGH NA RESULT WAS MMOL/L 144 MMOL/L. THE LOW RESULT WAS 116 MMOL/L WITH A DATA FLAG. THE HIGH K RESULT WAS MMOL/L 6.0 MMOL/L WITH A DATA FLAG. THE LOW RESULT WAS 3.9 MMOL/L. THE HIGH CL RESULT WAS MMOL/L 117 MMOL/L WITH A DATA FLAG. THE LOW RESULT WAS 103 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418665 ROCHE 9180 ELECTROLYTE ANALYZER ELECTROLYTE ANALYZER JFP ROCHE DIAGNOSTICS ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown