BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 303 ANALYTICAL UNIT

    MDR report key: 23121509 · Received September 23, 2025

    Report

    Report Number
    1823260-2025-03432
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    August 4, 2025
    Report Date
    October 13, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K220134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER (FSE) PERFORMED THE YEARLY MAINTENANCE AND VERIFIED THAT THE INSTRUMENT IS OPERATING WITHIN SPECIFICATIONS. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE; IT WAS DETERMINED THAT THE SERVICE ACTION RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE CREATININE REAGENT LOT NUMBER IS 863540, AND THE EXPIRATION DATE IS 31-DEC-2025. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE CREATININE RESULT FROM THE COBAS C 303 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 260 MOL/L. THE PATIENT PREVIOUSLY HAD NORMAL CREATININE RESULTS. WITH A NEW SAMPLE ON (B)(6) 2025, THE RESULT ON A DIFFERENT COBAS PURE WAS 55.7 MOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200817 COBAS C 303 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown