BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE 9180 ELECTROLYTE ANALYZER

    MDR report key: 23009086 · Received September 9, 2025

    Report

    Report Number
    1823260-2025-02804
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 20, 2025
    Report Date
    November 17, 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

    FOR THE PATIENT WITH A MONTH LONG ABSENCE OF BOWEL MOVEMENTS, ALSO KNOWN AS SEVERE CONSTIPATION, DOESN'T DIRECTLY AFFECT BLOOD CHLORIDE (CL) OR SODIUM (NA+) LEVELS. ELECTROLYTE IMBALANCES ARE NOT A TYPICAL FEATURE OF CONSTIPATION. FOR THE PATIENT WITH DIARRHEA, THE CONDITION IS MORE LIKELY TO CAUSE ELECTROLYTE IMBALANCES. THE INVESTIGATION CONFIRMED THAT THE REPORTED ISSUE WITH ERRONEOUS SODIUM (NA) RESULTS WAS CAUSED BY A DEFECTIVE NA ELECTRODE (LOT# 31250347). THE ANALYSIS OF THE RETURNED PART SHOWED NO PHYSICAL DEFECTS BUT CRITICALLY REVEALED THAT THE INNER ELECTROLYTE SOLUTION WAS COMPLETELY DRIED OUT. THIS WOULD PREVENT THE ELECTRODE FROM FUNCTIONING CORRECTLY. THE K ELECTRODE (LOT# 31245047) AND REFERENCE ELECTRODE (LOT# 200843) FROM THE SAME RETURN WERE FOUND TO BE FREE OF DEFECTS. INTERMITTENT FLUIDIC OBSTRUCTIONS ARE THE MOST LIKELY ROOT CAUSE FOR THE OBSERVED ISSUE WITH THE CHLORIDE ELECTRODE. A REVIEW OF ANALYZER ALARM DATA SHOWED MULTIPLE OBSTRUCTION ERRORS. AN OBSTRUCTION IN THE FLUIDIC PATH (NEEDLE, INLET PORT) WOULD CAUSE INCONSISTENT SAMPLE ASPIRATION, LEADING TO THE NON-REPRODUCIBLE RESULTS SEEN IN BOTH PATIENT SAMPLES AND QC. THIS ALIGNS WITH THE FIELD SERVICE ENGINEER'S ACTION OF DECONTAMINATING THE NEEDLE AND INLET PORT. A REVIEW OF THE CERTIFICATES OF ANALYSIS WAS PERFORMED FOR THE PROVIDED ELECTRODE LOT NUMBERS. THE DOCUMENTATION CONFIRMS THAT ALL COMPONENTS PASSED THE INTERNAL MANUFACTURING AND QUALITY CONTROL CHECKS, MEETING ALL REQUIRED SPECIFICATIONS. NO PRODUCT ISSUE IS FOUND. THE RECOMMENDED WORKAROUND IS TO REPLACE THE FAULTY ELECTRODE AND MAKE SURE THE INNER ELECTROLYTE IS SUFFICIENT.

    Additional Manufacturer Narrative · 0

    THE SODIUM ELECTRODE LOT NUMBER IS 31250347, WITH AN INSTALL BEFORE DATE OF 12-SEP-2025. THE CHLORIDE ELECTRODE LOT NUMBER WAS 31250547, WITH AN INSTALL BEFORE DATE OF 15-AUG-2025. THE FIELD SERVICE ENGINEER INSPECTED THE INSTRUMENT. THE ELECTRODES WERE REPLACED AND THE REFERENCE HOUSING WAS DEPROTEINIZED. THE NEEDLE AND INLET PORT WERE DECONTAMINATED. DAILY MAINTENANCE WAS PERFORMED. CALIBRATION AND CONTROLS RAN CORRECTLY. A PATIENT SAMPLE WAS PROCESSED SIX TIMES AND THE RESULTS WERE REPRODUCIBLE. A CALIBRATION REPORT PROVIDED FROM 22-AUG-2025 WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT SODIUM ELECTRODE RESULTS FOR TWO PATIENT SAMPLES TESTED ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE SECOND SAMPLE ALSO HAD DISCREPANT CHLORIDE ELECTRODE RESULTS. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST PATIENT SAMPLE RESULTED IN SODIUM VALUES OF 140 MMOL/L, 192.6 MMOL/L, AND 146.3 MMOL/L WITH A DATA FLAG. THE SECOND PATIENT SAMPLE RESULTED IN SODIUM VALUES OF 137.8 MMOL/L, 161.4 MMOL/L WITH A DATA FLAG, AND 173.1 MMOL/L WITH A DATA FLAG. THIS SAMPLE RESULTED IN CHLORIDE VALUES OF 108.8 MMOL/L, 96.2 MMOL/L WITH A DATA FLAG, AND 97.2 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2827646 ROCHE 9180 ELECTROLYTE ANALYZER ELECTROLYTE ANALYZER JFP ROCHE DIAGNOSTICS 04015630031832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown