BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 303 ANALYTICAL UNIT

    MDR report key: 25201389 · Received May 18, 2026

    Report

    Report Number
    1823260-2026-01936
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 18, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K220134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER WAS 921496. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) ADJUSTED THE MAIN PUMP PRESSURE, CORRECTED THE BASIC CLEANING SOLUTION CONSUMPTION SETTINGS, ADJUSTED THE SAMPLE PROBE, PERFORMED THE PIERCER MODIFICATION, ADJUSTED THE REAGENT PROBE, AND VERIFIED THE WATER FLOW RATES AND FILL VOLUMES AT THE WASH STATIONS. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT ALBUMIN GEN.2 RESULT FOR TWO URINE PATIENT SAMPLES TESTED ON THE COBAS C 303 ANALYTICAL UNIT. ONE EXAMPLE OF DISCREPANT RESULTS WAS PROVIDED: THE HIGH RESULT WAS 41,000 MG/L. THE LOW RESULT WAS 8,900 MG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535811 COBAS C 303 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1