BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 23634095 · Received November 24, 2025

    Report

    Report Number
    1823260-2025-04804
    Event Type
    Malfunction
    Date Received
    November 24, 2025
    Date of Event
    November 3, 2025
    Report Date
    December 10, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE CENTRIFUGATION TIME MAY HAVE BEEN SHORTER AND THE SPEED MAY HAVE BEEN HIGHER THAN RECOMMENDED BY THE TUBE MANUFACTURER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE TOTAL PROTEIN REAGENT LOT NUMBER WAS 883217. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED. THE GLUCOSE REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER FOUND A CLOT ATTACHED TO A SAMPLE PROBE. THE PROBE WAS CLEANED. THE CELL RINSE WATER AND WASH LEVELS WERE ADJUSTED. A WASH STATION WAS CLEANED OF BUILDUP. THE PROBE ADJUSTMENTS AND PROBE RINSE VOLUMES WERE VERIFIED. PRECISION AND ACCURACY TESTING WAS PERFORMED USING CONTROL MATERIAL AND PATIENT MATERIAL. THE ANALYZER WAS WORKING WITHIN SPECIFICATIONS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH GLUCOSE HK GEN.3 AND TOTAL PROTEIN GEN.2 ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN THE FOLLOWING VALUES: GLUCOSE = 49.6 MG/DL TOTAL PROTEIN = 2.38 G/DL. THE INITIAL RESULTS WERE QUESTIONED BECAUSE THEY WERE NOT CONSISTENT WITH THE PATIENT'S CONDITION. THE SAMPLE WAS REPEATED ON A SECOND ANALYZER AND THE REPEAT VALUES WERE: GLUCOSE = 105 MG/DL TOTAL PROTEIN = 7.12 G/DL. THE REPEAT VALUES WERE DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2309895 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female