BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROCHE 9180 LITHIUM ELECTRODE

    MDR report key: 23356247 · Received October 22, 2025

    Report

    Report Number
    1823260-2025-04288
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    September 19, 2025
    Report Date
    December 23, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIH
    UDI-DI
    04015630028795
    PMA / PMN Number
    K961458
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INSTRUMENT MAINTENANCE WAS LAST PERFORMED ON 25-APR-2025. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE SAMPLE PROBE, THE TUBING SET, THE REFERENCE ELECTRODE HOUSING, THE QUAD RING, AND THE NEEDLE ADAPTER. THE ISSUE WAS NOT RESOLVED FOLLOWING THE SERVICE ACTIONS. THE INSTRUMENT WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION REVIEWED THE QC RESULTS. THE RESULTS WERE WITHIN THE SPECIFIED RANGES. THE INVESTIGATION DETERMINED THAT THE CUSTOMER USES A REFERENCE ELECTRODE MANUFACTURED BY DIAMOND DIAGNOSTICS. 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 IS 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. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ROCHE 9180 LITHIUM ELECTRODE RESULTS FROM SEVENTEEN PATIENT SAMPLES TESTED ON THE ROCHE 9180 ELECTROLYTE ANALYZER. THE FOLLOWING EXAMPLES OF DISCREPANT RESULTS FOR FIVE PATIENT SAMPLES WERE PROVIDED: ON (B)(6) 2025: PATIENT SAMPLE. THE INITIAL RESULT WAS 0.47 MMOL/L. THE REPEAT RESULT WAS 0.59 MMOL/L. PATIENT SAMPLE 2 (FROM A CAPILLARY BLOOD SAMPLE). THE INITIAL RESULT WAS 0.53 MMOL/L. THE REPEAT RESULT WAS 0.40 MMOL/L. ON (B)(6) 2025: PATIENT SAMPLE 3 (FROM A SERUM BLOOD SAMPLE). THE INITIAL RESULT WAS 0.76 MMOL/L. THE REPEAT RESULT WAS 0.95 MMOL/L. ON (B)(6) 2025: PATIENT SAMPLE 4 (FROM A SERUM BLOOD SAMPLE). THE INITIAL RESULT WAS 0.44 MMOL/L. THE REPEAT RESULT WAS 0.54 MMOL/L. ON (B)(6) 2025: PATIENT SAMPLE 5 (FROM A SERUM BLOOD SAMPLE). THE INITIAL RESULT WAS 0.44 MMOL/L. THE REPEAT RESULT WAS 0.54 MMOL/L. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY, AS THE RESULTS WERE INCONSISTENT WITH THE PATIENT'S STATUS AND WERE IMPLAUSIBLE. THE REPEAT RESULTS WERE REPORTEDLY FROM A BACKUP SYSTEM AND WERE DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241358 ROCHE 9180 LITHIUM ELECTRODE ION-SPECIFIC ELECTRODE TEST FOR LITHIUM JIH ROCHE DIAGNOSTICS 04015630028795

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male