BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 24419494 · Received February 23, 2026

    Report

    Report Number
    1823260-2026-00634
    Event Type
    Malfunction
    Date Received
    February 23, 2026
    Date of Event
    January 29, 2026
    Report Date
    March 23, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE QC WAS ACCEPTABLE. A GENERAL REAGENT ISSUE WAS EXCLUDED. THE FIELD SERVICE REPRESENTATIVE ADJUSTED THE PROBE, OPTIMIZED THE REACTION CELL AND OUTSIDE RINSE WATER VOLUMES, AND PERFORMED CHECKS AND TESTS WITH ACCEPTABLE RESULTS. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 883217. THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE LOW RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR MULTIPLE ASSAYS ON A COBAS C 503 ANALYTICAL UNIT. DISCREPANT RESULTS WERE PROVIDED FOR 1 PATIENT SAMPLE TESTED FOR TOTAL PROTEIN GEN.2. THE INITIAL RESULT WAS 5.8 G/DL. THE REPEATED RESULTS WERE 7.2 G/DL AND 7.2 MG/DL. THE REPEATED RESULTS WERE OBTAINED ON ANOTHER MODULE AND WERE BELIEVED TO BE CORRECT. THE SAMPLE WAS REPEATED BECAUSE MULTIPLE LOW RESULTS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476510 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male