BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 23585958 · Received November 18, 2025

    Report

    Report Number
    1823260-2025-04696
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 24, 2025
    Report Date
    January 26, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INCOMPLETE CALIBRATION AND QC DATA WERE PROVIDED FOR INVESTIGATION. MULTIPLE "ABNORMAL ASPIRATION" ALARMS WERE OBSERVED ON THE ALARM TRACE DATA; HOWEVER, THESE DID NOT OCCUR ON THE DAY OF THE EVENT. THE FIELD SERVICE ENGINEER (FSE) FOUND A DIRTY SAMPLE PROBE AND EXCESSIVE SALT BUILDUP ON THE SONIC WASH STATION. THE FSE REPLACED THE SAMPLE PROBE AND CLEANED THE SONIC WASH STATION. PRECISION AND QC RESULTS WERE ACCEPTABLE. THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO A MAINTENANCE ISSUE.

    Additional Manufacturer Narrative · 0

    THE LI REAGENT LOT NUMBER WAS 811769 WITH AN EXPIRATION DATE OF 31-MAY-2026. THE CUSTOMER HAD CLEANED THE SAMPLE PROBE DUE TO RECURRING CLOT ALARMS.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF QC ISSUES WITH LITHIUM (LI) ON A COBAS C 503 ANALYTICAL UNIT. DISCREPANT RESULTS WERE IDENTIFIED FOR 1 PATIENT SAMPLE. THE INITIAL LI RESULT WAS 1.8 MMOL/L. THE DOCTOR REQUESTED REPEAT TESTING. THE REPEAT ON A DIFFERENT C503 ANALYZER WAS 0.6 MMOL/L. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69128 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown