BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 16269286 · Received January 30, 2023

    Report

    Report Number
    2432235-2023-00026
    Event Type
    Malfunction
    Date Received
    January 30, 2023
    Date of Event
    January 6, 2023
    Report Date
    January 30, 2023
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414573564
    PMA / PMN Number
    K971418
    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

    A UNITED STATES (US) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) TO REPORT THAT ERRONEOUS CARCINOEMBRYONIC ANTIGEN (CEA) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON AN ADVIA CENTAUR XP INSTRUMENT. PRIOR TO CONTACTING SIEMENS, THE CUSTOMER CHANGED THE REAGENT, RECALIBRATED THE ASSAY, AND RAN PATIENT SAMPLES IN DUPLICATE. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. DURING THE VISIT, THE CSE CHECKED THE WASH STATION AND FOUND THE WASH MANIFOLD WAS POOLING UNDER DISPENSE PORT WASH DISPLACEMENT AND A LEAK AT THE MAIN MANIFOLD IN THE FLUID'S DRAWER. THE CSE REPLACED TWO CONNECTORS ON THE WASH STATION AND PRIMED THE INSTRUMENT. THEN, THE CSE RAN QC, WHICH RECOVERED ACCEPTABLY. THE CAUSE OF THE ERRONEOUS CEA RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. MDRS 2432235-2023-00022, 2432235-2023-00023, 2432235-2023-00024, 2432235-2023-00025, 2432235-2023-00027, 2432235-2023-00028, 2432235-2023-00030, 2432235-2023-00029, 2432235-2023-00040, AND 2432235-2023-00041 WERE FILED FOR THE RESULTS OBTAINED ON 20-DEC-2022, 21-DEC-2022, 22-DEC-2022, 27-DEC-2022, 29-DEC-2022, 03-JAN-2023, 05-JAN-2023, 09-JAN-2023, 10-JAN-2023, AND 11-JAN-2023.

    Description of Event or Problem · 0

    A FALSELY ELEVATED CARCINOEMBRYONIC ANTIGEN (CEA) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA CENTAUR XP INSTRUMENT. THE ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED MULTIPLE TIMES. ULTIMATELY, THE RESULT OF <0.5 NG/ML WAS REPORTED, AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS CEA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896783 ADVIA CENTAUR XP ADVIA CENTAUR XP JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP 00630414573564

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown