BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 24815193 · Received April 8, 2026

    Report

    Report Number
    1823260-2026-01330
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    March 13, 2026
    Report Date
    May 29, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CREATININE PLUS VER.2 ASSAY RESULTS FOR SEVERAL PATIENT SAMPLES TESTED ON THE COBAS C 503 ANALYTICAL UNIT. SAMPLE 1: THE INITIAL RESULT WAS 35 MOL/L. THE REPEAT RESULTS WERE 94 MOL/L AND 97 ¿MOL/L. SAMPLE 2: THE INITIAL RESULT WAS 80 MOL/L. THE REPEAT RESULTS WERE 38 MOL/L AND 38 MOL/L. SAMPLE 3: THE INITIAL RESULT WAS 132 MOL/L. THE REPEAT RESULTS WERE 74 MOL/L AND 74 MOL/L. SAMPLE 4: THE INITIAL RESULT WAS 169 MOL/L. THE REPEAT RESULT WAS 89.3 MOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471583 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1