BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 303 ANALYTICAL UNIT

    MDR report key: 22782718 · Received August 12, 2025

    Report

    Report Number
    1823260-2025-02448
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    June 29, 2025
    Report Date
    September 5, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K220134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERVICE MAINTENANCE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE GLUCOSE REAGENT LOT NUMBER IS 860069 AND THE CREATININE REAGENT LOT NUMBER IS 863540. THE EXPIRATION DATES WERE AS NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE CUVETTES WERE OVERFILLING IN THE RINSE UNIT AND ADJUSTED THE FILLING LEVELS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR GLUCOSE HK GEN.3 RESULT WITH ONE PATIENT SAMPLE AND CREATININE PLUS VER.2 RESULT WITH ONE PATIENT SAMPLE ON A COBAS PURE C 303 ANALYTICAL UNIT. THE CUSTOMER QUESTIONED THE INITIAL RESULTS AS THEY DID NOT MATCH THE PATIENTS' CLINICAL PICTURES, WHICH PROMPTED THEM TO REPEAT THE SAMPLES. ON (B)(6) 2025, SAMPLE 1 HAD AN INITIAL CREATININE RESULT OF 54.9 MMOL/L. THE REPEAT RESULT WAS 128 MMOL/L. ON (B)(6) 2025, SAMPLE 2 HAD AN INITIAL GLUCOSE RESULT OF 2.31 MMOL/L. THE REPEAT RESULT WAS 5.25 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350053 COBAS C 303 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown