BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 303 ANALYTICAL UNIT

    MDR report key: 23829166 · Received December 17, 2025

    Report

    Report Number
    1823260-2025-05162
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    November 26, 2025
    Report Date
    March 18, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K220134
    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 TINA-QUANT FERRITIN GEN.4 REAGENT LOT NUMBERS ARE 875921 AND 905227, AND THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED STANDARD WATER PRESSURE ADJUSTMENTS AND REVIEWED THE CUSTOMER'S PRE-ANALYTICAL PROCEDURES. THE FSR FOUND THAT THE CUSTOMER USED A CENTRIFUGATION TIME OF 11 MINUTES (SPECIFICATION IS 10 MINUTES) WITH A FORCE OF 2500 G (SPECIFICATION IS 1300 - 2000 G). THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO PREANALYTICAL HANDLING ISSUES (EXCESSIVE G-FORCE AND EXTENDED TIMING OUTSIDE OF SPECIFICATION).

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT FERRITIN GEN.4 RESULT FROM THE COBAS C 303 ANALYTICAL UNIT FOR TWO PATIENTS. PATIENT 1'S INITIAL RESULT WAS 7.07 NG/ML, AND THE REPEAT RESULT WAS 15.9 NG/ML. THE REPEAT RESULT ON ANOTHER ANALYZER WAS 15 NG/ML. THE SAMPLE WAS REPEATED BECAUSE IT DID NOT AGREE WITH THE PATIENT'S PREVIOUS RESULTS. THE REPEAT RESULTS WERE DEEMED TO BE CORRECT. PATIENT 2'S INITIAL RESULT ON (B)(6) 2025 WAS 8.22 NG/ML, AND THE REPEAT RESULT WAS 13 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2193149 COBAS C 303 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown