BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DCA VANTAGE

    MDR report key: 22368544 · Received July 1, 2025

    Report

    Report Number
    3002637618-2025-00051
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Date of Event
    November 4, 2024
    Report Date
    September 4, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CGX
    UDI-DI
    00630414551364
    PMA / PMN Number
    K071466
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAS STATED THAT THEY WERE PERFORMING PROPER MAINTENANCE AND PASSING QUALITY CONTROLS. THE CUSTOMER COMMUNICATED THAT THEY DID NOT HAVE ANY REMAINING REAGENT AVAILABLE. WITHOUT THE RETURNED REAGENT, AN INVESTIGATION CANNOT PROCEED AND THEREFORE THE ROOT CAUSE CANNOT BE DETERMINED. THE DCU REVIEWED THE CERTIFICATE OF ANALYSIS FOR LOT IN USE AT THE TIME OF THE EVENT, AND THE PRODUCT MET AND PASSED ALL SPECIFICATIONS UPON MANUFACTURING RELEASE. THE CAUSE OF THIS EVENT IN UNKNOWN. NO PRODUCT PROBLEM IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THE AFFECTED TEST DUE TO THE DEVICE MALFUNCTION IS CREATININE. HENCE THE PRODUCT CODE IS CHANGED TO CGX IN THE SECTION D2A.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY RECEIVED DISCREPANT MICROALBUMIN, CREATININE AND ALBUMIN-CREATININE RATIO RESULT ON THEIR DCA VANTAGE INSTRUMENT COMPARED TO LAB TEST. THE PATIENT'S RESULTS WERE CONFIRMED FROM THE LAB TEST. THERE IS NO REPORTED INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381910 DCA VANTAGE DCA VANTAGE CGX SIEMENS HEALTHCARE DIAGNOSTICS INC. 00630414551364

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown