BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 23350467 · Received October 21, 2025

    Report

    Report Number
    1823260-2025-04282
    Event Type
    Malfunction
    Date Received
    October 21, 2025
    Date of Event
    September 30, 2025
    Report Date
    October 21, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CHOL2 REAGENT LOT NUMBER WAS 855587 WITH AN EXPIRATION DATE OF 30-NOV-2025. THE TP2 REAGENT LOT NUMBER WAS 883217 WITH AN EXPIRATION DATE OF 31-AUG-2026. THE GLUCOSE REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) FOUND AN ISSUE WITH THE SAMPLE COVER SPRING; THE SPRING WAS COMPRESSED AND NOT PUSHING DOWN ON THE SAMPLE PROBE, CAUSING IT TO STICK UP. THE FSE REPLACED THE SPRING. PRECISION TESTS WERE WITHIN SPECIFICATION. THE INVESTIGATION DETERMINED THAT THE ISSUE FOUND BY THE FSE WAS THE ROOT CAUSE OF THE EVENT.

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED THE RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR MULTIPLE ASSAYS ON A COBAS C 503 ANALYTICAL UNIT. DISCREPANT RESULTS WERE PROVIDED FOR 3 PATIENT SAMPLES TESTED FOR CHOLESTEROL GEN.2 (CHOL2), GLUCOSE, AND TOTAL PROTEIN GEN.2 (TP2). PATIENT 1 INITIAL CHOL2 RESULT WAS 36 MG/DL. THE REPEAT RESULT WAS 211 MG/DL. PATIENT 2 INITIAL GLUCOSE RESULT WAS 19.5 MG/DL. THE REPEAT RESULT WAS 72.9 MG/DL. PATIENT 3 INITIAL CHOL2 RESULT WAS 77 MG/DL. THE REPEAT RESULT WAS 188 MG/DL. THE INITIAL TP2 RESULT WAS 0.8 G/DL. THE REPEAT RESULT WAS 6.6 G/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974977 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown