BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE 9180 LITHIUM ELECTRODE

    MDR report key: 25260105 · Received May 22, 2026

    Report

    Report Number
    1823260-2026-02053
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    May 4, 2026
    Report Date
    May 22, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIH
    PMA / PMN Number
    K961458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ROCHE 9180 LITHIUM ELECTRODE RESULTS FROM THE ELECTROLYTE ANALYZER MOD 9180. THE SAMPLES WERE REPEATED AT ANOTHER LABORATORY USING AN UNKNOWN ANALYZER(S). SAMPLE 1 INITIAL RESULT WAS < 0.10 MMOL/L. THIS WAS QUESTIONED AS THE PATIENT WAS UNDERGOING DRUG THERAPY. THE REPEAT RESULT ON AN UNKNOWN DATE WAS 0.53 MMOL/L. THE FOLLOWING SAMPLES WERE INITIALLY TESTED ON (B)(6) 2026, AND REPEATED ON (B)(6) 2026. SAMPLE 2 RESULTS WERE <0.10, 0.20, AND 0.20 MMOL/L. SAMPLE 3 RESULTS WERE 0.17, 0.40, AND 0.40 MMOL/L. SAMPLE 4 RESULTS WERE 0.39, 0.60, AND 0.70 MMOL/L. SAMPLE 5 RESULTS WERE 0.46, 0.70, AND 0.80 MMOL/L. SAMPLE 6 RESULTS WERE 0.39, 0.50, AND 0.60 MMOL/L. THE FOLLOWING SAMPLES WERE INITIALLY TESTED ON (B)(6) 2026. SAMPLE 7 INITIAL RESULT WAS 0.63 MMOL/L, AND THE REPEAT RESULT WAS 0.80 MMOL/L. SAMPLE 8 INITIAL RESULT WAS <0.10 MMOL/L, AND THE REPEAT RESULT WAS 0.2 MMOL/L. SAMPLE 9 INITIAL RESULT WAS 0.30 MMOL/L, AND THE REPEAT RESULT WAS 0.40 MMOL/L. SAMPLE 10 INITIAL RESULT WAS 0.58 MMOL/L, AND THE REPEAT RESULT WAS 0.70 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130642 ROCHE 9180 LITHIUM ELECTRODE ION-SPECIFIC ELECTRODE TEST FOR LITHIUM JIH ROCHE DIAGNOSTICS 31260347

    Patients

    Seq Age Sex Outcome Treatment
    1