BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE 9180 ELECTROLYTE ANALYZER

    MDR report key: 22936804 · Received September 2, 2025

    Report

    Report Number
    1823260-2025-02689
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    August 8, 2025
    Report Date
    October 23, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIH
    UDI-DI
    04015630031832
    PMA / PMN Number
    K961458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) DETERMINED THAT TWO OF THE UPPER TUBES WERE INCORRECTLY CONNECTED. THE FSE RESOLVED THE ISSUE BY CORRECTLY CONNECTING THE TUBES. HOWEVER, IN AN EFFORT TO REPRODUCE THE ISSUE, OUR TEAM ATTEMPTED TO EXCHANGE THE TUBES IN THE ROCHE LAB, FOLLOWING THE FSE'S EXPLANATION. WE WERE UNABLE TO REPRODUCE THE ORIGINAL ISSUE. INSTEAD, AFTER EXCHANGING THE TUBES, NO CALIBRATION COULD BE PERFORMED. A PERSISTENT ERROR MESSAGE, "CLOG CHECK FLUID PATH," APPEARED DURING THE CALIBRATION PROCESS. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    UPDATED MEDWATCH FIELD D. SUSPECT MEDICAL DEVICE, COMMON DEVICE NAME, PRODUCT CODE.

    Additional Manufacturer Narrative · 0

    THE LITHIUM REAGENT LOT AND EXPIRATION DATE WERE NOT PROVIDED. QC WAS PASSING AT THE TIME OF THE EVENT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE LITHIUM RESULTS FROM THE ROCHE 9180 ELECTROLYTE ANALYZER FOR 8 PATIENTS. PATIENT 1'S INITIAL RESULT WAS 0.76 MMOL/L, AND THE REPEAT RESULT WAS 1.15 MMOL/L. PATIENT 2'S INITIAL RESULT WAS 0.20 MMOL/L, AND THE REPEAT RESULT WAS 0.94 MMOL/L. PATIENT 3'S INITIAL RESULT WAS 0.30 MMOL/L, AND THE REPEAT RESULT WAS 0.57 MMOL/L. PATIENT 4'S INITIAL RESULT WAS 0.28 MMOL/L, AND THE REPEAT RESULT WAS 0.51 MMOL/L. PATIENT 5'S INITIAL RESULT WAS 0.39 MMOL/L, AND THE REPEAT RESULT WAS 0.68 MMOL/L. PATIENT 6'S INITIAL RESULT WAS 0.26 MMOL/L, AND THE REPEAT RESULT WAS 0.66 MMOL/L. PATIENT 7'S INITIAL RESULT WAS 0.97 MMOL/L, AND THE REPEAT RESULT WAS 1.27 MMOL/L. PATIENT 8'S INITIAL RESULT WAS 1.45 MMOL/L, AND THE REPEAT RESULT WAS 0.40 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828410 ROCHE 9180 ELECTROLYTE ANALYZER ELECTROLYTE ANALYZER JIH ROCHE DIAGNOSTICS 04015630031832

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown