BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 22914312 · Received August 28, 2025

    Report

    Report Number
    1823260-2025-02649
    Event Type
    Malfunction
    Date Received
    August 28, 2025
    Date of Event
    August 6, 2025
    Report Date
    October 31, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CREP2 REAGENT LOT NUMBER WAS 863540 WITH AN EXPIRATION DATE OF 31-DEC-2025. THE GLUCOSE REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) IDENTIFIED A CLOT IN THE SAMPLE PROBE. THE FSE REPLACED THE SAMPLE PROBE AND CHECKED ADJUSTMENTS. PRECISION RESULTS WERE WITHIN SPECIFICATION. NO CALIBRATION ISSUES WERE IDENTIFIED. QC WAS ACCEPTABLE. THERE WAS NO INDICATION OF A REAGENT PERFORMANCE ISSUE. SAMPLE QUALITY ALARMS WERE OBSERVED ON THE ALARM TRACE DATA. THE SERVICE ACTIONS RESOLVED THE ISSUE. THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO A MAINTENANCE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR CREATININE PLUS VER.2 (CREP2) ON A COBAS C 503 ANALYTICAL UNIT. OF THE DATA PROVIDED, A DISCREPANT HIGH GLUCOSE RESULT WAS IDENTIFIED. THE INITIAL CREP2 RESULT WAS 2.48 MG/DL. THE INITIAL RESULT DID NOT CORRESPOND TO THE PATIENT¿S CLINICAL PICTURE, AND THE SAMPLE WAS REPEATED. THE REPEAT RESULT WAS 1.58 MG/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT. THE INITIAL GLUCOSE RESULT WAS 140 MG/DL. THE REPEAT RESULT WAS 98.9 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2608331 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown