BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 503 ANALYTICAL UNIT

    MDR report key: 21653271 · Received March 20, 2025

    Report

    Report Number
    1823260-2025-00806
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Date of Event
    March 5, 2025
    Report Date
    March 20, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K191899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HBA1C REAGENT LOT NUMBER IS 801767, THE EXPIRATION DATE WAS NOT PROVIDED. A FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THERE WAS A BLOCKED SAMPLE VALVE. THE FSE CLEANED THE FLOW PATH, REPLACED THE SAMPLE VALVE AND SAMPLE PROBES, AND ADJUSTED THE CELL FILLING VOLUME. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTION RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE HBA1C RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. A DOCTOR QUESTIONED A PATIENT'S RESULT, SO THE CUSTOMER BEGAN REPEATING SAMPLES. IN REPEATING OTHER HBA1C RESULTS, ON (B)(6) 2025 A SECOND PATIENT WAS DISCOVERED WITH QUESTIONABLE RESULTS. THE INITIAL RESULT WAS 18.5%, AND THE REPEAT RESULT WAS 5.11%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331838 COBAS C 503 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown