BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 303 ANALYTICAL UNIT

    MDR report key: 24862903 · Received April 13, 2026

    Report

    Report Number
    1823260-2026-01405
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    March 22, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    07613336220153
    PMA / PMN Number
    K220134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ELECTRODE LOT NUMBER IS FFY WITH AN EXPIRATION DATE OF 30-SEP-2026. THE FIELD SERVICE REPRESENTATIVE FOUND THAT THE O-RING WAS MISSING FROM THE ACRYLIC BLOCK AND THE SIPPER NOZZLE NUT WAS UPSIDE DOWN. HE REPLACED THE MISSING O-RING AND CORRECTLY INSTALLED THE SIPPER NOZZLE NUT. HE PERFORMED CHECKS AND TESTS WITH ACCEPTABLE RESULTS. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE CALIBRATION AND QC WERE ACCEPTABLE. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM ELECTRODE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 134.2 MMOL/L. THE REPEATED RESULT WAS 139.8 MMOL/L. NEITHER RESULT WAS BELIEVED TO BE CORRECT. THE SAMPLE WAS REPEATED BECAUSE THE CUSTOMER NOTICED THE NEGATIVE ANON GAP IN THE MIDDLEWARE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104317 COBAS C 303 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 07613336220153

    Patients

    Seq Age Sex Outcome Treatment
    1